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.

Admission to trading on AIM & First Day of Dealings

Capitalised terms used in this announcement shall, unless the context provides otherwise, have the same meaning as defined in the Admission Document.

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that admission to trading on AIM ("Admission") will take place and dealings will commence at 8.00 a.m. today under the ticker VRCI and ISIN GB00BM8HZD43.

The Company’s Admission Document is available here.

 

Key Highlights:

 

About Verici Dx

The Company is an immuno-diagnostics development company, initially focussed on the kidney transplantation market. The Company's kidney transplant assays will use advanced next-generation sequencing that may define a personalised risk profile of each patient over the course of their transplant journey, and may also detect injury in advance of currently available clinical tests.

The Company develops tests to understand how a patient is likely to, and may be, responding to kidney transplant. There are two leading products for clinical validation and commercialisation:

In terms of validation trials, the Company is preparing to initiate a comprehensive multi-centre observational clinical study, commencing shortly after receipt of the net proceeds from the Fundraising.  The primary study objective is to validate the clinical performance of gene expression immune-phenotyping signatures and associated algorithms for both Clarava™ and Tuteva™.

In terms of commercialisation, the Company intends to continue building its collaborative, multi-centre working group to further develop, validate and commercialise its products and technology platform.

In terms of reimbursement, the Company intends to seek coverage and reimbursement for Clarava™ and Tuteva™ products with Medicare Administrative Contractors of the Centers for Medicare & Medicaid Services (“CMS”) and major third-party private payors in the US.

Prior to full commercial scaling, the Company expects to focus its first revenues from a small number of early adopting sites. This is expected to be within 24 months of the Admission, subject to successful validation trials and approvals under CLIA certification.

 

Kidney Transplant Need

Globally, there are approximately 95,000 transplants performed each year of which about 24,000 are performed in the US and some 25,000 in Europe. The comparatively low number in comparison to the waiting list in the US was recognised as an issue for patients waiting for a transplant for on average 3 to 5 years, even longer in some geographical locations.

It also formed part of the policy in the US Executive Order, Advancing American Kidney Health, where the agency was required to improve efficiencies in the transplant network and expand support for living donors, with the goal of doubling the number of available transplants by 2030.

It is estimated that about 37 to 50 per cent. of all grafts will experience a clinical (10 to 15 per cent.) or subclinical (27 to 40 per cent.) rejection condition in the first year following transplant and clinicians use immunosuppression therapy to try to manage the rejection risk. Despite that, the failure rate in the US has remained largely unchanged and is 16 per cent. (live donor) to 28 per cent. (cadaver) at 5 years. In the EU this is 13 to 21 per cent. respectively.

 

Use of Proceeds

The net proceeds of the Fundraising of approximately £13.5 million will be used by the Company as follows:

The balance, being approximately £4.2 million, will be available as a contingency against delays in revenue or increased costs and providing additional working capital beyond the 21 month period following Admission.

 

Sara Barrington, CEO of Verici Dx, said:

“We are very grateful for the strong support shown by institutional and other investors to the Verici Dx IPO.  Obtaining funding in a public market is a strong signal of quality to prospective partners and customers, raises the profile of the business and its innovative products considerably, and gives us a supportive platform as we advance our strategy.  We look forward to providing further updates on the execution of our validation and commercialisation plans as we deploy the capital raised towards addressing a significant unmet clinical need.”

 


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.

 

IMPORTANT INFORMATION

 

This announcement does not constitute, or form part of, any offer or invitation to sell, allot or issue, or any solicitation of any offer to purchase or subscribe for, any securities in the Company in any jurisdiction nor shall it, or any part of it, or the fact of its distribution, form the basis of, or be relied on in connection with or act as an inducement to enter into, any contract or commitment therefor.

Recipients of this announcement who are considering subscribing for or acquiring New Ordinary Shares are reminded that any such acquisition or subscription must be made only on the basis of the information contained in the final Admission Document. To the fullest extent permitted by applicable law or regulation, no undertaking, representation or warranty, express or implied, is given by or on behalf of the Company, Nplus1 Singer Advisory LLP (“N+1 Singer”)  or their respective parent or subsidiary undertakings or the subsidiary undertakings of any such parent undertakings or any of their respective directors, officers, partners, employees, agents, affiliates, representatives or advisers or any other person as to the accuracy, sufficiency, completeness or fairness of the information, opinions or beliefs contained in this announcement and, save in the case of fraud, no responsibility or liability is accepted by any of them for any errors, omissions or inaccuracies in such information or opinions or for any loss, cost or damage suffered or incurred, howsoever arising, from any use, as a result of the reliance on, or otherwise in connection with this announcement.  N+1 Singer does not accept any liability, whatsoever, for the accuracy of any information or opinions contained in this announcement or for the omission of any information from this announcement for which the Company and the directors are solely responsible.

N+1 Singer, which is authorised and regulated by the Financial Conduct Authority, is acting only for the Company in connection with the proposed Placing and Admission and is not acting for or advising any other person, or treating any other person as its client, in relation thereto and will not be responsible for providing the regulatory protection afforded to clients of N+1 Singer or advice to any other person in relation to the matters contained herein. Such persons should seek their own independent legal, investment and tax advice as they see fit. N+1 Singer's responsibilities as the Company's nominated adviser under the AIM Rules for Nominated Advisers and AIM Rules for Companies will be owed solely to the London Stock Exchange and not to the Company, to any of its directors or to any other person in respect of a decision to subscribe for or otherwise acquire Ordinary Shares in reliance on the Admission Document. N+1 Singer has not authorised or approved the contents of, or any part of, this announcement and no representation or warranty, express or implied, is made by N+1 Singer or its affiliates as to any of its contents.

This announcement is only addressed to, and directed at, persons in member states of the European Economic Area who are qualified investors within the meaning of Article 2(e) of the Prospectus Regulation (EU) 2017/1129 ("Qualified Investors"). In addition, in the United Kingdom, this announcement is addressed to and directed only at Qualified Investors who are (i) persons having professional experience in matters relating to investments, i.e., investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "FPO"); (ii) high net-worth companies, unincorporated associations and other bodies within the meaning of Article 49 of the FPO; and (iii) persons to whom it is otherwise lawful to communicate it to. It is not intended that this announcement be distributed or passed on, directly or indirectly, to any other class of person and in any event, and under no circumstances should persons of any other description rely on or act upon the contents of this announcement.

Neither this announcement nor any copy of it may be (i) taken or transmitted into, distributed, published, reproduced or otherwise made available, directly or indirectly, in the United States (within the meaning of Regulation S under the US Securities Act of 1933, as amended (the "US Securities Act")), (ii) taken or transmitted into, distributed, published, reproduced or otherwise made available or disclosed in Australia, Canada, New Zealand or the Republic of South Africa or to any resident thereof, except in compliance with applicable securities laws, or (iii) taken or transmitted into or distributed in Japan or to any resident thereof for the purpose of solicitation or subscription or offer for sale of any securities or in the context where the distribution thereof may be construed as such a solicitation or offer. Any failure to comply with these restrictions may constitute a violation of the securities laws or the other laws of any such jurisdiction. The distribution of this announcement in other jurisdictions may be restricted by law and the persons into whose possession this announcement comes should inform themselves about, and observe, any such restrictions.

The New Ordinary Shares have not been and will not be registered under the US Securities Act, and may not be offered or sold in the United States, except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the US Securities Act. No public offering of securities is being made in the United States. Neither the US Securities and Exchange Commission nor any state securities commission or other regulatory authority in the United States has approved or disapproved of the New Ordinary Shares or passed upon or endorsed the merits of the offering of the New Ordinary Shares or the adequacy or accuracy of this announcement. Any representation to the contrary is a criminal offence in the United States.

 No securities commission or similar authority in Canada has in any way passed on the merits of the securities offered hereunder and any representation to the contrary is an offence. No document in relation to the proposed placing of the New Ordinary Shares has been, or will be, lodged with, or registered by, the Australian Securities and Investments Commission, and no registration statement has been, or will be, filed with the Japanese Ministry of Finance. Accordingly, subject to certain exceptions, the New Ordinary Shares may not be, directly or indirectly, offered, sold, taken up, delivered or transferred in or into or from any jurisdiction in which the same would be unlawful or offered or sold to a person within such a jurisdiction.

This announcement contains certain statements that are, or may be, forward looking statements with respect to the financial condition, results of operations, business achievements and/or investment strategy of the Company. Such forward looking statements are based on the Board's expectations of external conditions and events, current business strategy, plans and the other objectives of management for future operations, and estimates and projections of the Company's financial performance. Though the Board believes these expectations to be reasonable at the date of this announcement, they may prove to be erroneous. Forward looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, achievements or performance of the Group, or the industry in which the Group operates, to be materially different from any future results, achievements or performance expressed or implied by such forward looking statements.

Certain figures in this announcement, including financial information, have been subject to rounding adjustments. Accordingly, in certain instances, the sum or percentage change of the numbers contained in this announcement may not conform exactly to the total figure given.

 

Information to Distributors 

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the New Ordinary Shares have been subject to a product approval process, which has determined that the New Ordinary Shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Ordinary Shares may decline and investors could lose all or part of their investment; the New Ordinary Shares offer no guaranteed income and no capital protection; and an investment in the New Ordinary Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offer. Furthermore, it is noted that, notwithstanding the Target Market Assessment, N+1 Singer will only procure investors who meet the criteria of professional clients and eligible counterparties.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Ordinary Shares. 

Each distributor is responsible for undertaking its own target market assessment in respect of the Ordinary Shares and determining appropriate distribution channels.

 

Successful Restricted Offer Update on Fundraising and Admission


Capitalised terms in this announcement carry the same definitions as in prior announcements in relation to the Fundraising.


 

Verici Dx plc, a developer of advanced clinical diagnostics for organ transplant, announces the result of the Restricted Offer made to its shareholders, who returned a valid application form to subscribe for Verici Dx Ordinary Shares of £0.001 each (“Verici Shares”) at the Issue Price, being 20 pence per share (the “Restricted Offer”).

The Restricted Offer for up to £0.5 million was significantly oversubscribed as expected.

The Placing, Subscription and Restricted Offer have, in aggregate, raised £14.5 million through the issue of a total of 72,500,000 new Ordinary Shares at the Issue Price.

The allotment and issue of Verici Dx Shares in connection with the Restricted Offer remains conditional upon, among other things, Admission, which is expected to take place on 3 November.

Applicants to the Restricted Offer can confirm their final allotment of shares by contacting the helpline on 0371 664 0321. Calls are charged at the standard geographic rate and will vary by provider. Calls outside the United Kingdom will be charged at the applicable international rate. The helpline is open between 9.00 a.m. and 5.30 p.m., Monday to Friday excluding public holidays in England and Wales. Different charges may apply to calls from mobile telephones and calls may be recorded and randomly monitored for security and training purposes. The helpline cannot provide advice on the merits of the Proposals nor give any financial, legal or tax advice.

Full details of the Fundraising will be contained in the Verici Dx Admission Document, which will be made available shortly before Admission at www.vericidx.com

 

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

Intention to admit to trading on AIM Proposed placing, subscription and a Restricted Offer

Not for release, publication or distribution, directly or indirectly, in whole or in part, in, into or within the United States, Australia, Canada, Hong Kong, Japan, New Zealand, the Republic of South Africa or any other jurisdiction where it is unlawful to distribute this announcement.


Verici Dx plc, a developer of advanced clinical diagnostics for organ transplant, announces that it intends to apply to have its issued share capital, as enlarged by a proposed placing, subscription and a Restricted Offer (as defined below) (together, the “Fundraising”), admitted to trading on AIM in due course (“Admission”).

This announcement follows on from recent updates provided by Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), on 2 September 2020 and 8 July 2020, and this release is being linked to the RENX ticker for information purposes only.

The Company is pleased to confirm that it intends to launch a restricted offer as part of the Fundraising. The restricted offer will enable certain qualifying Company shareholders in the UK to subscribe for ordinary shares in the Company (“Verici Shares”) (the “Restricted Offer”) on the same terms and at the same price per share as participants in the placing and subscription.

The Restricted Offer is only available to certain persons, being persons who held the beneficial title to any A Shares of £0.001 each in the capital of the Company on 10 July 2020 (the “Record Date”) whose registered address is in the UK (“Qualifying Shareholders”) (being persons recorded on the register of members of Renalytix AI plc on 9 July 2020). This document sets out further details of the Restricted Offer.

 

Full details of the Restricted Offer can be found in the Pathfinder (draft) Admission Document (Pathfinder) available online to Qualifying Shareholders only at www.vericidx.com.

Please note that the Pathfinder Admission Document is drafted as though written on the intended publication date of the final form Admission Document, and so describes certain matters that are still in progress as though they have happened.

Qualifying Shareholders who wish to consider applying for Verici Shares in the Restricted Offer should first read the Pathfinder in its entirety, including but not limited to the Important Information section, Part 1 (Information on the Company, the Market Opportunity and Strategy), Part 2 (Risk Factors), the Restricted Offer terms which will apply to any application for Verici Shares made under the Restricted Offer as are set out in Part 7 (Restricted Offer Terms), and the Q&A relating to the Restricted Offer set out in Part 8 (Restricted Offer Q&A).

Any Qualifying Shareholder should carefully consider if a further investment in the Company is suitable for their investment parameters and risk profile and are recommended to take independent advice from their own personal financial adviser, stockbroker, bank manager, solicitor, accountant or other independent financial adviser authorised under the FSMA. For the avoidance of doubt neither the directors of the Company nor Nplus1 Singer Advisory LLP, the Company’s nominated adviser and corporate broker, is making any recommendation as to what action Qualifying Shareholders should take and the Restricted Offer is being organised solely by the Company.

 

EIS Relief

The Company wishes to draw the attention of Qualifying Shareholders to the provisions of s.164A ITA 2007, which prohibits such a Qualifying Shareholder from claiming EIS tax relief if that Qualifying Shareholder holds the beneficial title to any existing shares in Verici at the time of an issue of new shares (including any Verici Shares to be subscribed for as part of the Restricted Offer) in the Company.

 

Process for Participating in the Restricted Offer

The application form for participation in the Restricted Offer will only become available online once the Fundraising has been priced following a bookbuild exercise. An announcement will be made confirming that sufficient funds have been raised in the placing and subscription and will confirm the pricing details.  A separate announcement will also confirm that the Restricted Offer will then be open to applications. These announcements are expected on or shortly after Monday 19 October 2020.  Letters will also be sent to Qualifying Shareholders to alert them to the commencement of the Restricted Offer and the availability of the application form.

Qualifying Shareholders who wish to confirm their interest in participating in the Restricted Offer prior to the formal commencement of applications may register their interest through the Company website at the following address www.vericidx.com where they may also register for future shareholder alerts to be sent to them by email.  All such Qualifying Shareholders registering on the website prior to 11.00 a.m. on Friday 16 October 2020 to will also receive an email from the Company or LINK as its agent, alerting them to the commencement of the Restricted Offer and the availability of the application form.

Once open, the Restricted Offer will be open for a maximum of 5 business days and the Company reserves the right to close the Restricted Offer sooner. Qualifying Shareholders are therefore encouraged to register their details electronically via the website to avoid delays in receiving the letter alerting them to the commencement of the Restricted Offer application process and also to check the Company’s website and other news sources from Monday 19 October 2020.

The application form will ONLY be made available online and after the pricing announcement has been made via a regulatory information service, a further letter (and for those Qualifying Shareholders who have registered their details online, also a further email) will be sent containing details of how to access the online form.

Following the application period, the Company will announce the result of the Restricted Offer, confirm the finalisation of the Fundraising and the expected Admission date for Verici Shares to commence trading on AIM.

The Company may, in its absolute discretion, offer any Verici Shares for which applications have not been made or accepted in the Restricted Offer to other participants in the wider Fundraising, including those who may not be Qualifying Shareholders, as it deems fit.

 

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. One of the most significant threats to a successful transplant, or graft, is the body’s own immune system. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterizing 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.

 

Disclaimer

This announcement is an advertisement for the purposes of the Prospectus Regulation Rules of the UK Financial Conduct Authority (“FCA”) and is not a prospectus nor an admission document.  This announcement is not and does not constitute, or form part of, and should not be construed as, an offer or invitation to sell, allot or issue or any solicitation of any offer to purchase or subscribe for, any securities of the Company in any jurisdiction, nor shall it (or any part of it) or the fact of its distribution form the basis of, or be relied upon in connection with, or act as any inducement to enter into, any contract or commitment for securities in the Company in any jurisdiction, including in or into the United States, Canada, Australia, the Republic of South Africa or Japan or their respective territories or possessions.. This announcement does not constitute a recommendation regarding any securities.

Prospective investors should not subscribe for or purchase any securities referred to in this announcement except in compliance with applicable securities laws and regulation and on the basis of the information in the Pathfinder, the placing proof of the admission document and the final admission document (“Admission Document”) to be published by the Company, and any supplement thereto, in connection with the Fundraising and the proposed admission of the issued and to be issued ordinary shares to trading on AIM. The information in this announcement is for background purposes only and does not purport to be full or complete.

Verici Dx completes the Board of Directors with the appointment of Sir Ian Carruthers OBE

Sir Ian’s extensive and high level experience with NHS compliments the current Board’s experience with both US and UK healthcare environments

NEW YORK, (September, 2020) — Verici Dx Plc (Verici), announced the appointment to the Board of Directors of Sir Ian Carruthers.  Sir Ian is experienced in the public, private and voluntary sectors and has operated as a Chief Executive within the health service for over twenty years, including as Interim Chief Executive of NHS England, where he oversaw an annual budget of £86 billion and 1.3 million employees.

“We are delighted to welcome Sir Ian to our talented and experienced Board,” said Julian Baines Chairman of the Board, “and we feel that he will make an important contribution as the Company commercializes its products improving kidney transplant care.”

The Company also appointed Sara Barrington as Chief Executive Officer. She brings over 20 years of leadership experience both financially and operationally with a focus upon developing and commercializing life science products.

About Verici Dx

Verici Dx develops tests to understand how a patient will and is responding to organ transplant. One of the most significant threats to a successful transplant, or graft, is the body’s own immune system. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterizing 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.

Approval of distribution of shares in Verici Dx Limited and related party transaction

Download full announcement

NEW YORK, 8 July, 2020 – Renalytix AI plc (LSE: RENX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and lower healthcare costs, announces that it now proposes to distribute shares in its wholly-owned subsidiary, Verici Dx Limited (“Verici”).

Following the approval by shareholders at a general meeting held on 15 May 2020 of the reduction of capital and the confirmation of the High Court in England and Wales on 9 June 2020, the cancellation of the Company’s share premium account has been completed and the reduction of capital became effective on 6 July 2020.

On 7 July 2020 the Board  convened and declared a distribution in specie of shares in Verici to trustees on trust for the Company’s shareholders (the “Distribution”). Verici’s share capital has been re-designated into 59,416,134 A Shares of £0.001 each and 1 golden share of £0.001 (the “Golden Share”). The Golden Share will be the only voting share in the capital of Verici and will be retained by the Company. The Company’s shareholders on the register as at close of business on 9 July 2020 (“Relevant Renalytix Shareholders“) will receive one A Share in Verici (“Distribution Shares”) for every 1 ordinary share held in the Company. Broadway Nominees Limited, as trustees, will act as legal holder of the Distribution Shares and the undertaking can be accessed on the Company’s website under the investor section.

Relevant Renalytix Shareholders will become the beneficial owners of their respective Distribution Shares when the Board resolves to declare the Distribution, at which time an ‘omnibus’ share certificate in respect of the Distribution Shares will be issued, to be held by the trustees on behalf of the Relevant Renalytix Shareholders for a period of:

During the Lock-up Period, Relevant Renalytix Shareholders will not be permitted to transfer the legal or beneficial ownership of their Distribution Shares.

The A Shares and the Golden Share will, on the earlier of the admission to trading of Verici on AIM (or another recognised stock exchange) and two years from the date that the Distribution is declared, automatically convert into Ordinary Shares in Verici on the basis of one Ordinary Share for each A Share or Golden Share held. If Verici is admitted to trading on AIM (or another recognised stock exchange), the Lock-up Period will continue to apply to the converted Ordinary Shares. Upon conversion, the A Shares will rank equally in all respects with the Golden Share (and all other Ordinary Shares) including in respect of voting and dividend rights.

The legal title to the Distribution Shares will be held by Broadway Nominees Limited, as trustees, during the Lock-Up Period. If the A Shares are converted into Ordinary Shares prior to the expiration of the Lock-up Period, Broadway Nominees Limited will withhold its votes in relation to any shareholder resolution of Verici. At the end of the Lock-up Period, Broadway Nominees Limited will execute stock transfer forms to transfer the Distribution Shares to the Relevant Renalytix Shareholders based on a schedule provided by the Company’s registrars.

Relevant Renalytix Shareholders will receive a letter informing them of their beneficial holdings of Distribution Shares shortly after the declaration of the Distribution.

Following the Lock-up Period, Relevant Renalytix Shareholders will receive individual certificates in respect of their Distribution Shares.

On 4 May 2020 the Company transferred the in-licensed FractalDx technology and associated assets to Verici for a consideration of $2,000,000 (“Consideration”). The Consideration was satisfied by the issue of convertible loan notes of Verici in favour of the Company (“Loan Notes”). The Loan Notes are repayable (if the Company so determines), amongst other things, on the completion of a fundraising in Verici or 12 months from the date of the instrument constituting the Loan Notes, unless the Company determines to convert the Loan Notes into ordinary shares in Verici at the time of a fundraising in Verici. The Loan Notes are secured by a debenture over Verici in favour of the Company and  no interest shall accrue on the Loan Notes.

The anticipated timetable for the distribution is:

Record date for the Distribution close of business on 9 July 2020
RenalytixAI ordinary shares marked as ex rights   Start of trading on 10 July 2020
Transfer of shares in Verici 10 July 2020

Related party transaction

As part of RenalytixAI’s preparations for a potential dual-listing on Nasdaq, The Icahn School of Medicine at Mount Sinai (“Mount Sinai”), a substantial shareholder in the Company, has requested that RenalytixAI enter into a registration rights agreement pursuant to which RenalytixAI will, at its own cost and expense, assist Mount Sinai in the registration of Mount Sinai’s ordinary shares for resale under the U.S. Securities Act of 1933, as amended. The registration rights agreement contains customary indemnities given by RenalytixAI in respect of any loss suffered by Mount Sinai and certain of its associated persons (as well as the underwriters on any underwritten follow-on offering by Mount Sinai) arising out of any material misstatements made in or omissions from the public filings related to the potential Nasdaq dual-listing and/or the resale of Mount Sinai’s ordinary shares. These indemnities are of a customary nature and are uncapped.

The entry by RenalytixAI into the registration rights agreement together with the obligations contained within it is deemed to be a related party transaction pursuant to AIM Rule 13 as Mount Sinai is a substantial shareholder in the Company. The directors of the Company, excluding Erik Lium and Barbara Murphy, who are not considered to be independent for this purpose on account of their connection with Mount Sinai, having consulted with the Company’s nominated adviser, Stifel, consider the terms of the registration rights agreement to be fair and reasonable insofar as the Company’s shareholders are concerned.

Update re. potential demerger of FractalDx and distribution in specie

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Proposed capital reduction and notice of General Meeting

Renalytix AI plc (LSE: RENX), the AIM-traded developer of clinical grade artificial intelligence in vitro diagnostics for kidney disease, announces that a circular (a “Circular”) will today be sent to shareholders providing background to, details of and reasons for, a proposed Capital Reduction and Distribution in Specie, to facilitate the possible spin-out and admission to AIM of FractalDx, the Company’s technology portfolio of diagnostic and prognostic products, in-licensed from Mount Sinai in late 2018. Definitions contained in the Circular have the same meaning as in this announcement.

On 3 March 2020, the Company announced in its half-year report that the Board was considering options for a possible spin-out and admission to AIM of FractalDx. Such a spin-out transaction could:

The Board has now determined to take the necessary preliminary steps in preparation for a potential spin-out, including the incorporation of a new subsidiary, Verici Dx Limited. The Company has decided to proceed in obtaining the approval necessary for the Capital Reduction which isrequired to implement the Demerger. Notwithstanding that the necessary approval for the Capital Reduction is being sought, these considerations remain at an early stage and there can be no guarantee that the Demerger will be completed. The approval of the Capital Reduction enables the Board to declare distribution in specie of Verici Dx shares to existing RenalytixAI shareholders. Further announcements will be made at the appropriate time.

The Board is seeking approval from Shareholders at the General Meeting to cancel the share premium account of the Company in its entirety in order to create realised profits. The realised profits created by the Capital Reduction will eliminate the accumulated deficit in the Company’s profit and loss account and will be used to implement the Distribution in Specie and improve the Company’s distributable reserves.

Background and reasons for the Capital Reduction and Distribution in Specie

As announced in its half-year report on 3 March 2020, the Company has been evaluating its plans for its FractalDx technology, in-licensed from Mount Sinai in late 2018, which is based on extensive scientific research findings published in leading clinical journals (“FractalDx”). The FractalDx technology is based principally on sequencing biomarkers from a patient’s blood using widely available instrument platforms and the Company is actively developing two products from the portfolio: a prognostic test performed prior to transplant to predict which transplant recipients are most at risk of acute rejection; and a diagnostic test for evidence of rejection of the transplanted kidney in advance of any clinical symptoms. The Board believe that both tests will be instrumental in guiding patient care including immunosuppression therapy dosing to mitigate the toxic side effects and damage to the transplanted kidney due to excessive dosing.

Having considered these plans in further detail, the Board has decided that a spin-out and admission to AIM of FractalDx may provide the opportunity to secure separate financial resources for the FractalDx portfolio, with the goal of enabling accelerated development of FractalDx products and achievement of commercial milestones. It is anticipated that a spin-out pursuant to the Demerger would allow the Company’s shareholders to benefit from both the pure-play value of the FractalDx portfolio of transplant products and the standalone value of KidneyIntelX as it progresses through its own key milestones.

The Company is in the process of completing various steps in anticipation of the implementation of the potential Demerger, including the transfers to Verici Dx Limited, the Company’s recently incorporated wholly owned subsidiary, of the in-licensed FractalDx technology and associated assets (the “Assets”).

The purchase price for the Assets will be their current book value (which is currently $2 million) and these funds will be lent to Verici Dx Limited by the Company pursuant to a secured zero interest inter-company facility agreement (the “Facility”). The Facility allows for Verici Dx Limited to make further drawdowns to be used in the development of the Verici Dx business. The Company may seek full repayment of the Facility on either the date that is twelve months from the date the Facility is entered into (“Anniversary Date”) or on completion of the Fundraising (if prior to the Anniversary Date) or the Company may convert the debt outstanding under the Facility into equity in Verici Dx Limited either: (i) prior to the Distribution in Specie; or (ii) on or around completion of the Fundraising (if prior to the Anniversary Date in both cases), with such equity also being subject to the Lock-In Period.

The Directors believe that the FractalDx portfolio has the potential to deliver significant upside value for Shareholders. The Directors are therefore exploring funding options for that business, including equity funding, and the Directors intend on conducting initial market soundings in order to assist them in determining the feasibility of an initial public offering. Further announcements will be made at the appropriate time.

The Company expects to distribute shares in Verici Dx Limited to Shareholders by way of the Distribution in Specie. However, the Company currently has negative reserve balances. In order to implement the Distribution in Specie, it will therefore first be necessary to create realised profits. Moreover, the Board considers it highly desirable that the Company has the maximum flexibility to consider the payment of dividends and otherwise return value to its shareholders in the future.

The Company’s Share Premium Account currently stands at approximately $50,138,270. As at 31 December 2019 the Company had a retained earnings deficit of $3,216,493. It is proposed that all of the Share Premium Account be cancelled.

The purpose of the cancellation of the Share Premium Account is to eliminate the deficit on the Company’s profit and loss account and to create distributable reserves in the Company to facilitate the:

The value of the Distribution in Specie (the “Value”) has not yet been determined and the amount of Verici Dx Shares (the “Ratio”) that each Shareholder would receive pursuant to the Distribution in Specie has not yet been determined. Subject to the results of the market sounding exercise, the Board intends to declare the Distribution in Specie shortly prior to completion of the Fundraising, at which point the Value and the Ratio will be determined and announced to Shareholders via an RIS.

Subject to the results of the market sounding exercise, the Board intends to declare a distribution in specie of:

The Company plans to use an external agent to establish a trust over the legal interest in the Distribution Shares for the duration of the Lock-In Period, pursuant to a nominee arrangement. The intention is that the agent will transfer legal title to the Distribution Shares following the end of the Lock-In Period.

Shareholders should note that the Board does not intend to declare the Distribution in Specie until the Fundraising process is near conclusion. The Fundraising process is in its early stages and so the Fundraising and Admission may or may not occur. The Distribution in Specie therefore may or may not occur. In the event that the Distribution in Specie does not occur Verici Dx Limited will remain within the Renalytix Group and continue to be operated as a subsidiary of the Company. The reserves created by the Capital Reduction which were intended to be used in the implementation of the Distribution in Specie will be used, as with the balance of the reserves, to facilitate the future consideration of payment of dividends to Shareholders and the possible redemption or buy back of the Company’s shares where desirable.

Full details are set out in the Circular which has today been posted to Shareholders and is available here: https://renalytixai.com/investors/company-presentation/ in accordance with AIM Rule 20.

Further details on the Capital Reduction procedure

Under the Act, a company limited by shares may reduce or cancel its share premium account as long as it is not restricted from doing so by is articles of association, by obtaining the approval of its shareholders by special resolution and the confirmation of the Court.

The Company is not restricted in any way by its articles of association from carrying out a reduction of capital and is, therefore, seeking approval of its shareholders to the Capital Reduction. If the Shareholders approve the Resolution at the General Meeting, the Board intends to make an application to the Court to obtain its approval to the Capital Reduction as soon as possible following the General Meeting.

Before it confirms the Capital Reduction, the Court will need to be satisfied that the creditors of the Company at the time of the Capital Reduction (including contingent and prospective creditors) cannot show that there is a real likelihood that the Capital Reduction would result in the Company being unable to discharge those debts or claims when they fall due, or that the creditors are otherwise satisfactorily protected. The Company will address those matters in its evidence to the Court, including seeking the consent of some of the Company’s creditors to the Capital Reduction.

Provisional dates have been obtained for the required Court hearings of the Company’s application, but they are subject to change and dependent on the Court’s timetable. If the hearings go ahead on the provisional dates, the present timetable provides that the final hearing, at which it is hoped that the Court will make an order confirming the Capital Reduction, will take place on 9 June 2020.

The Capital Reduction does not take effect until the Court’s order is filed with and registered by Companies House. The Board intends to file the required documentation with Companies House on the business day following the final Court hearing and, subject to compliance with all procedural requirements, Companies House will usually register the documents on the same day. On the present timetable, which is subject to change and dependent on the Court’s timetable, this would mean that the Capital Reduction would take effect on 10 June 2020.

Notice of General Meeting

The Capital Reduction and Distribution in Specie are conditional upon, inter alia, the Shareholders approving the Resolution at the General Meeting.

In light of the current UK Government’s public health advice in response to the COVID-19 outbreak, including to limit travel and public gatherings, and the likelihood that this advice may remain in place at the time of the General Meeting, the Company is holding the General Meeting electronically.

The Circular contains a notice convening the General Meeting to be held electronically at 12.00 p.m. on 15 May 2020 at which the Resolution will be proposed. The Company will provide a facility for Shareholders to join the General Meeting either online or by telephone and there will be an opportunity for Shareholders to ask questions relating to the matters to be dealt with at the General Meeting. In order to facilitate the process, and so that questions can be fully answered at the end of the meeting, the Board would request questions to be submitted in advance, before 5.00 p.m. (BST) on 13 May 2020.

To register for dial-in details and to submit any questions please contact Walbrook PR via email at renalytix@walbrookpr.com or call +44 (0)20 7933 8780.

Shareholders should note that, unless the Capital Reduction is approved at the General Meeting, the spin-out of FractalDx cannot take place.

Recommendation

The Directors consider that the Capital Reduction and Distribution in Specie will promote the success of the Company for the benefit of the Shareholders as a whole. Accordingly, the Directors unanimously recommend that Shareholders vote in favour of the Resolution, as the Directors intend to do in respect of their own beneficial holdings of 16,645,157 Ordinary Shares, representing approximately 28.01 per cent. of the Company’s entire issued share capital as at the date of this document.