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.
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.
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.
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.
“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.”
Sara Barrington, CEO
Julian Baines, Chairman
www.patientjourney.vericidx.com
Via Walbrook PR
N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen
Tel: 020 7496 3000
Walbrook PR Limited
Paul McManus / Sam Allen
Tel: 020 7933 8780 or [email protected]
Mob: 07980 541 893 / 07748 651 727
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.
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.
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.
