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RNS Number : 8655N Genedrive PLC 09 May 2024
THIS ANNOUNCEMENT (INCLUDING THE APPENDICES) AND THE INFORMATION CONTAINED
HEREIN IS RESTRICTED AND IS NOT FOR PUBLICATION, RELEASE OR DISTRIBUTION,
DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OF
AMERICA, AUSTRALIA, CANADA, JAPAN OR THE REPUBLIC OF SOUTH AFRICA OR IN OR
INTO ANY OTHER JURISDICTION WHERE TO DO SO MIGHT CONSTITUTE A VIOLATION OR
BREACH OF ANY APPLICABLE LAW OR REGULATION.
THIS ANNOUNCEMENT (INCLUDING THE APPENDICES) IS FOR INFORMATION PURPOSES ONLY
AND DOES NOT ITSELF CONSTITUTE AN OFFER FOR SALE OR SUBSCRIPTION OF ANY
SECURITIES IN THE COMPANY OR CONTAIN ANY INVITATION, SOLICITATION,
RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO SUBSCRIBE FOR, OTHERWISE
ACQUIRE OR DISPOSE OF ANY SECURITIES OF GENEDRIVE PLC IN ANY JURISDICTION.
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED IN ARTICLE 7 OF
REGULATION (EU) NO 596/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF
16 APRIL 2014 ON MARKET ABUSE (MARKET ABUSE REGULATION) AS RETAINED AS PART OF
UK LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 AS AMENDED.
UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION IS NOW
CONSIDERED TO BE IN THE PUBLIC DOMAIN.
genedrive plc
("genedrive", the "Group" or the "Company")
Proposed Fundraise to raise a minimum of £6.0 million to underpin and grow
operations and accelerate commercialisation
and
Notice of General Meeting
Manchester, UK - 9 May 2024: genedrive plc (LSE: GDR), the point of care
pharmacogenetic testing company, announces a proposed fundraising by way of a
placing (the "Placing") (incorporating a Firm Placing and a Conditional
Placing) to raise approximately £2.5 million in aggregate at a price per
share of 1.5 pence (the "Issue Price"). The Company also announces a
proposed financing on the "REX" platform to new and existing retail investors
at the Issue Price (the "REX Offer") to raise approximately £3.5 million and
that it will also be making an Open Offer to Qualifying Shareholders also at
the Issue Price to raise approximately £2.1 million (the "Open Offer", which
together with the Placing and the REX Offer is the "Fundraising").
Unless the Fundraising, in aggregate, raises gross proceeds of not less than
£6.0 million (the "Minimum Proceeds") it will not proceed other than the Firm
Placing (should that element of the Fundraising become unconditional).
The Issue Price of 1.5 pence per share represents a discount of approximately
57.1 per cent. To the closing price on 8 May 2024 (being the latest
practicable date prior to this Announcement). No part of the Fundraising is
being underwritten.
Reasons for the Fundraising and Use of Proceeds
The net proceeds of the Fundraising will be used amongst other things to
underpin and grow the Group's operations and accelerate commercialisation
throughout the UK, Europe and the Middle East and to fund clinical studies and
regulatory submissions in the U.S. for the Group's MT-RNR1 ID kit ("AIHL
test") having recently contracted with a leading multi-state physician
organisation in the U.S. to support clinical studies required for engagement
with the U.S. Food and Drug Administration ("FDA"). Further details are set
out below under paragraph 6 "Use of Proceeds".
Details of the Fundraising
The Fundraising comprises:
· A non-pre-emptive firm placing (the "Firm Placing") of up to
11,173,994 new Ordinary Shares at the Issue Price, raising gross proceeds of
up to approximately £0.17 million. The Firm Placing is not conditional upon
Shareholder approval or the Minimum Proceeds being raised;
· A non-pre-emptive conditional placing (the "Conditional Placing") of
approximately 155,492,673 new Ordinary Shares at the Issue Price, raising
gross proceeds of approximately £2.3 million. The Conditional Placing is
conditional on, inter alia, the passing of the Resolutions by Shareholders at
a general meeting of the Company expected to be convened later this month (the
"General Meeting") and the Minimum Proceeds being raise;
· A REX Offer of up to 233,333,333 new Ordinary Shares at the Issue
Price, raising gross proceeds of up to approximately £3.5 million. The REX
Offer is conditional on, inter alia, the passing of the Resolutions by
Shareholders at the General Meeting and the Minimum Proceeds being raised; and
· An Open Offer at the Issue Price on the basis of 1 Open Offer
Share for every 1 Ordinary Share held on the Record Date, to raise gross
proceeds of up to approximately £2.1 million for the Company. The Open Offer
will be made to Qualifying Shareholders pursuant to the Circular. The Open
Offer is also conditional on the passing of the Resolutions at the General
Meeting and the Minium Proceeds being raised.
Investors who subscribe for Firm Placing Shares are advised that, as
previously disclosed, the Company's current cash runway is through May 2024
and there is no certainty that the proceeds of the Conditional Placing, the
Rex Offer or the Open Offer will be received by the Company as these elements
of the Fundraising remain subject to several conditions including Shareholder
approval and the Minimum Proceeds being raised. Should the Company receive
the net proceeds from the Firm Placing but no proceeds from the Conditional
Placing, the Rex Offer or the Open Offer, its cash runway will remain
extremely limited, it will only have around seven weeks of working capital and
the Company would urgently need to seek further financing which may or may not
be available at all or, if available, may be on commercially unacceptable
terms and could lead to more substantial dilution for Shareholders than would
be the case under the proposed Fundraising.
Peel Hunt LLP ("Peel Hunt") is acting as sole bookrunner and sole broker and
nominated adviser, in connection with the Fundraising. The Placing Shares are
being offered by way of an accelerated bookbuild, which will be launched
immediately following this Announcement (as defined below), in accordance with
the terms and conditions set out in Appendix II to this Announcement.
The timing for the close of the Bookbuild and allocation of the Placing Shares
shall be at the discretion of Peel Hunt, in consultation with the Company. The
final number of Placing Shares will be agreed by Peel Hunt and the Company at
the close of the Bookbuild and the result will be announced as soon as
practicable thereafter.
The Company has separately engaged Peel Hunt to undertake an intermediaries
offer of the REX Offer Shares at the Issue Price to new and existing retail
investors through its 'REX' platform, alongside the Firm Placing, the
Conditional Placing and the Open Offer.
The REX Offer Shares are not part of the Placing and are not Placing Shares.
The REX Offer is not underwritten or made subject to the terms and conditions
set out in Appendix II to this Announcement. However, the issue and allotment
of the REX Offer Shares is conditional, amongst other things, on Shareholder
approval being granted at the General Meeting and the Minimum Proceeds being
raised.
As the REX Offer will not be underwritten, if there is no take up by new and
existing retail investors, or the take up under the REX Offer and the Open
Offer is not sufficient to ensure that (together with the Placing) the Minimum
Proceeds are raised, no additional proceeds will be received by genedrive
pursuant to the REX Offer element of the Fundraising.
The Open Offer will not be underwritten so if there is no take up by
Qualifying Shareholders, or the take up under the Open Offer and the REX Offer
is not sufficient to ensure that (together with the Placing) the Minimum
Proceeds are raised, no additional proceeds will be received by genedrive
pursuant to the Open Offer element of the Fundraising.
A separate announcement will be made shortly by the Company regarding the REX
Offer and its terms and conditions.
No prospectus will be published in connection with the REX Offer.
In addition, in order to ensure Qualifying Shareholders have the opportunity
to participate in the equity financing at the Issue Price, the Company will
also be conducting an Open Offer, on the basis of 1 Open Offer Share for every
1 Ordinary Share held on the Record Date, to raise gross proceeds of up to
approximately £2.1 million for the Company. The Open Offer will be made to
Qualifying Shareholders pursuant to the Circular. Shareholders subscribing
for their full entitlement under the Open Offer may also apply for additional
Open Offer Shares through the Excess Application Facility. The Open Offer is
primarily aimed at those Qualifying Shareholders who are not given the
opportunity to participate in the Placing or the REX Offer.
The Conditional Placing, the REX Offer and the Open Offer are conditional,
inter alia, upon the Minimum Proceeds being raised and Shareholders approving
the Resolutions at the General Meeting and upon the Placing and Open Offer
Agreement not having been terminated and becoming unconditional. The Company
intends to publish and send the Circular to Qualifying Shareholders by 14 May
2024, which will contain a notice convening the General Meeting and proposing
the necessary resolutions to authorise the Directors to allot the Conditional
Placing Shares, the REX Offer Shares and the Open Offer Shares for cash free
of statutory pre-emption rights. It will also contain the terms and conditions
of the Open Offer. The Circular will be available on the Company's website
after publication: https://www.genedriveplc.com/
(https://www.genedriveplc.com/) .
The Placing Shares are not being made available to the public and are only
available to Relevant Persons. The Open Offer Shares will only be available to
Qualifying Shareholders.
Set out below in Appendix I is an extract from the draft Circular that is
proposed to be sent to Shareholders in due course.
This Announcement should be read in its entirety. In particular, your
attention is drawn to the detailed terms and conditions of the Placing in
Appendix II to this Announcement. Further information relating to the
Fundraising and use of proceeds is set out in Appendix I to this Announcement.
By choosing to participate in the Placing (including the Firm Placing) and by
making an oral and legally binding offer to acquire Placing Shares, investors
will be deemed to have read and understood this Announcement in its entirety
(including the Appendices), and to be making such offer on the terms and
subject to the conditions of the Placing contained herein, and to be providing
the representations, warranties and acknowledgements contained in Appendix II.
Unless otherwise indicated, capitalised terms in this Announcement have the
meaning given to them in the definitions section included in Appendix III.
The ticker for the Company's ordinary shares is GDR. The Company's LEI is
213800ZYODIRZ87Y4K14.
The person responsible for arranging release of this announcement on behalf of
the Company is Russ Shaw, CFO.
Enquiries:
genedrive plc +44 (0) 161 989 0245
James Cheek (CEO)
Russ Shaw (CFO)
Peel Hunt LLP - Nominated Adviser, Broker and Bookrunner +44 (0) 20 7148 8900
James Steel / Patrick Birkholm (Investment Banking)
Sohail Akbar (ECM)
Walbrook PR - Financial PR & IR Adviser +44 (0) 20 7933 8780
Anna Dunphy / Paul McManus +44 (0) 7876 741 001 or +44 (0) 7980 541 893 or genedrive@walbrookpr.com
(mailto:genedrive@walbrookpr.com)
About genedrive plc (http://www.genedriveplc.com (http://www.genedriveplc.com)
) genedrive plc is a pharmacogenetic testing company developing and
commercialising a low cost, rapid, versatile and simple to use point of need
pharmacogenetic platform for the diagnosis of genetic variants. This helps
clinicians to quickly access key genetic information that will aid them make
the right choices over the right medicine or dosage to use for an effective
treatment, particularly important in time-critical emergency care healthcare
paradigms. Based in the UK, the Company is at the forefront of Point of Care
pharmacogenetic testing in emergency healthcare. Pharmacogenetics informs on
how your individual genetics impact a medicines ability to work for you.
Therefore, by using pharmacogenetics, medicine choices can be personalised,
made safer and more effective. The Company has launched its two flagship
products, the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit,
both developed and validated in collaboration with NHS partners and deployed
on its point of care thermocycler platform. Both tests are single-use
disposable cartridges which are ambient temperature stable, circumventing the
requirement for cold chain logistics. The Directors believe the Genedrive®
MT-RNR1 ID Kit is a worlds-first and allows clinicians to make a decision on
antibiotic use in neonatal intensive care units within 26 minutes, ensuring
vital care is delivered, avoiding adverse effects potentially otherwise
encountered and with no negative impact on the patient care pathway. Its
CYP2C19 ID Kit which has no comparably positioned competitor currently allows
clinicians to make a decision on the use of Clopidogrel in stroke patients
in 70 minutes, ensuring that patients who are unlikely to benefit from or
suffer adverse effects from Clopidogrel receive an alternative antiplatelet
therapeutic in a timely manner, ultimately improving outcomes. Both tests
have undergone review by the National Institute for Health and Care Clinical
Excellence ("NICE") and have been recommended for use in the UK NHS.
The Company has a clear commercial strategy focused on accelerating growth
through maximising in-market sales, geographic and portfolio expansion and
strategic M&A, and operates out of its facilities in Manchester.
IMPORTANT NOTICES AND DISCLAIMER
This announcement including its appendices (together, this "Announcement") and
the information contained in it is not for publication, release, transmission
distribution or forwarding, in whole or in part, directly or indirectly, in or
into the United States of America, Australia, Canada, Japan or the Republic of
South Africa or any other jurisdiction in which publication, release or
distribution would be unlawful. This Announcement is for information purposes
only and does not constitute an offer to sell or issue, or the solicitation of
an offer to buy, acquire or subscribe for shares in the capital of the Company
in the United States of America, Australia, Canada, Japan or the Republic of
South Africa or any other state or jurisdiction where to do so would be
unlawful. Any failure to comply with these restrictions may constitute a
violation of the securities laws of such jurisdictions. This Announcement has
not been approved by London Stock Exchange or by any other securities
exchange.
The new Ordinary Shares, have not been, and will not be, registered under the
U.S. Securities Act of 1933, as amended (the "Securities Act") or with any
securities regulatory authority of any state or other jurisdiction of the
United States of America and may not be offered, sold, pledged, taken up,
exercised, resold, renounced, transferred or delivered, directly or
indirectly, in or into the United States of America absent registration under
the Securities Act, except pursuant to an exemption from the registration
requirements of the Securities Act and in compliance with any applicable
securities laws of any state or other jurisdiction of the United States of
America. The Placing Shares are being offered and sold by the Company outside
of the United States of America in offshore transactions as defined in, and
pursuant to, Regulation S under the Securities Act.
This announcement is not being distributed by, nor has it been approved for
the purposes of section 21 of the Financial Services and Markets Act 2000, as
amended ("FSMA"), by a person authorised under FSMA. This announcement is
being directed to persons in the United Kingdom only in circumstances in which
section 21(1) of FSMA does not apply.
Members of the Public are not eligible to take part in the Placing. This
announcement is for information purposes only and is directed only at persons
who are: (1) in Member States of the European Economic Area, qualified
investors as defined in article 2(e) of the Prospectus Regulation (EU)
2017/1129 (the "EU Prospectus Regulation"); (2) in the United Kingdom,
qualified investors as defined in article 2(e) of Prospectus Regulation (EU)
2017/1129 as it forms part of UK domestic law by virtue of the European Union
(Withdrawal) Act 2018, as amended (the "UK Prospectus Regulation"), who (A)
fall within article 19(5) ("investment professionals") of the Financial
Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended
(the "Order"), or (B) fall within article 49(2)(a) to (d) ("high net worth
companies, unincorporated associations, etc.") of the Order; or (3) are
persons to whom it may otherwise be lawfully communicated; (all such persons
together being referred to as "relevant persons"). This announcement and the
terms and conditions set out herein must not be acted on or relied on by
persons who are not relevant persons. Persons distributing this announcement
must satisfy themselves that it is lawful to do so. Any investment or
investment activity to which this announcement and the terms and conditions
set out herein relates is available only to relevant persons and will be
engaged in only with relevant persons.
The new Ordinary Shares have not been approved, disapproved or recommended by
the U.S. Securities and Exchange Commission, any state securities commission
in the United States of America or any other U.S. regulatory authority, nor
have any of the foregoing authorities passed upon or endorsed the merits of
the offering of new Ordinary Shares. Subject to certain exceptions, the
securities referred to herein may not be offered or sold in the United States
of America, Australia, Canada, Japan or the Republic of South Africa or to, or
for the account or benefit of, any national, resident or citizen of the United
States of America, Australia, Canada, Japan or the Republic of South Africa.
No public offering of securities is being made in the United Kingdom, the
United States of America or any other jurisdiction. Offers of the new Ordinary
Shares will either be made pursuant to an exemption under the EU Prospectus
Regulation and the UK Prospectus Regulation (as such terms are defined above)
from the requirement to produce a prospectus or otherwise in circumstances not
resulting in an offer of transferable securities to the public under section
102B of FSMA.
This Announcement has been issued by, and is the sole responsibility of, the
Company. No representation or warranty, express or implied, is or will be made
as to, or in relation to, and no responsibility or liability is or will be
accepted by the directors or the Company, or by any of its or their respective
partners, employees, advisers, affiliates or agents as to or in relation to,
the accuracy or completeness of this Announcement or any other written or oral
information made available to or publicly available to any interested party or
its advisers, and any liability therefore is expressly disclaimed. None of
the information in the Announcement has been independently verified or
approved by Peel Hunt or any of its partners, directors, officers, employees,
advisers, consultants, affiliates or agents.
This Announcement contains inside information for the purposes of Article 7 of
UK MAR, encompassing information relating to the Placing described above, and
is disclosed in accordance with the Company's obligations under Article 17 of
UK MAR. In addition, market soundings (as defined in UK MAR) were taken in
respect of the Placing with the result that certain persons became aware of
inside information, as permitted by UK MAR. This inside information is set
out in this Announcement. Therefore, upon publication of this announcement,
those persons that received such inside information in a market sounding are
no longer in possession of such inside information relating to the Company and
its securities.
Peel Hunt, which is authorised and regulated in the United Kingdom by the FCA
is acting as nominated adviser, sole bookrunner and sole broker to the Company
and no one else in connection with the Placing and is not acting for and will
not be responsible to any person other than the Company for providing the
protections afforded to its clients or for providing advice in relation to the
Placing. Peel Hunt's responsibilities as the Company's nominated adviser under
the AIM Rules for Nominated Advisers are owed solely to London Stock Exchange
and are not owed to the Company or to any Director or to any other person in
respect of his decision to acquire shares in the Company in reliance on any
part of this Announcement.
Except as required under applicable law, neither Peel Hunt nor any of their
directors, officers, partners, members, employees, advisers, affiliates or
agents assume or accept any responsibility whatsoever for the contents of the
information contained in this Announcement or for any other statement made or
purported to be made by or on behalf of Peel Hunt or any of their affiliates
in connection with the Company, the new Ordinary Shares or the Placing. Peel
Hunt and each of their directors, officers, partners, members, employees,
advisers, affiliates and agents accordingly disclaim all and any
responsibility and liability whatsoever, whether arising in tort, contract or
otherwise (save as referred to above) in respect of any statements or other
information contained in this Announcement and no representation or warranty,
express or implied, is made by Peel Hunt or any of their directors, officers,
partners, employees, advisers, affiliates or agents as to the accuracy,
completeness or sufficiency of the information contained in this Announcement.
The distribution of this Announcement and/or the Placing in certain
jurisdictions may be restricted by law. No action has been taken by the
Company, Peel Hunt or any of their respective affiliates that would, or which
is intended to, permit an offering of the new Ordinary Shares in any
jurisdiction or result in the possession or distribution of this Announcement
or any other offering or publicity material relating to new Ordinary Shares in
any jurisdiction where action for that purpose is required.
This Announcement does not constitute a recommendation concerning any
investor's option with respect to the Placing. Each investor or prospective
investor should conduct his, her or its own investigation, analysis and
evaluation of the business and data described in this Announcement and
publicly available information. The price and value of securities can go down
as well as up. Past performance is not a guide to future performance. The
contents of this Announcement are not to be construed as legal, business,
financial or tax advice. Each investor or prospective investor should consult
with his or her or its own legal adviser, business adviser, financial adviser
or tax adviser for legal, financial, business or tax advice.
Persons (including without limitation, nominees and trustees) who have a
contractual right or other legal obligations to forward a copy of this
Announcement should seek appropriate advice before taking any action.
Neither the content of the Company's website nor any website accessible by
hyperlinks on the Company's website is incorporated in, or forms part of, this
Announcement.
Product Governance Requirements
Solely for the purposes of the product governance requirements of Chapter 3 of
the FCA Handbook Product Intervention and Product Governance Sourcebook (the
"UK Product Governance Requirements") and/or any equivalent requirements
elsewhere to the extent determined to be applicable, and disclaiming all and
any liability, whether arising in tort, contract or otherwise, which any
"manufacturer" (for the purposes of the UK Product Governance Requirements
and/or any equivalent requirements elsewhere to the extent determined to be
applicable, may otherwise have with respect thereto, the Placing Shares have
been subject to a product approval process, which has determined that the
Placing 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 defined in Chapter 3 of the FCA Handbook Conduct
of Business Sourcebook; and (ii) eligible for distribution through all
permitted distribution channels (the "Target Market Assessment").
Notwithstanding the Target Market Assessment, distributors should note that:
the price of the Placing Shares may decline and investors could lose all or
part of their investment; the Placing Shares offer no guaranteed income and no
capital protection; and an investment in the Placing 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 Placing. Furthermore, it is noted that, notwithstanding the
Target Market Assessment, Peel Hunt 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
Chapters 9A or 10A respectively of the FCA Handbook Conduct of Business
Sourcebook; 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 Placing Shares.
Each distributor is responsible for undertaking its own target market
assessment in respect of the Placing Shares and determining appropriate
distribution channels.
Forward Looking Statements
This Announcement contains "forward-looking statements" which include all
statements (other than statements of historical facts) including, without
limitation, those regarding the Group's financial position, business strategy,
plans and objectives of management for future operations, and any statements
preceded by, followed by or that include the words "targets", "believes",
"expects", "aims", "intends", "will", "may", "anticipates", "would", "could"
or "similar" expressions or negatives thereof. Such forward-looking statements
involve known and unknown risks, uncertainties and other important factors
beyond the Company's control that could cause the actual results, performance
or achievements of the Group to be materially different from future results,
performance or achievements expressed or implied by such forward-looking
statements. Such forward-looking statements are based on numerous assumptions
regarding the Group's present and future business strategies and the
environment in which the Group will operate in the future. These
forward-looking statements speak only as at the date of this Announcement. The
Company expressly disclaims any obligation or undertaking to disseminate any
updates or revisions to any forward looking statements contained herein to
reflect any change in the Company's expectations with regard thereto or any
change in events, conditions or circumstances on which any such statements are
based unless required to do so by applicable law or the AIM Rules for
Companies.
No statement in this Announcement is intended to be a profit forecast and no
statement in this Announcement should be interpreted to mean that earnings per
share of the Company for the current or future years would necessarily match
or exceed the historical published earnings per share of the Company.
This Announcement does not identify or suggest, or purport to identify or
suggest, the risks (direct or
indirect) that may be associated with an investment in the Placing Shares. Any
investment decisions
to buy Placing Shares in the Placing must be made solely on the basis of
publicly available information,
which has not been independently verified by Peel Hunt.
Appendix I - EXTRACTS FROM THE CIRCULAR
LETTER FROM THE CHAIRMAN
1. Background to and reasons for the Fundraising
Background
genedrive is a pharmacogenetic testing company developing and commercialising
a low cost, rapid, versatile and simple to use point of need pharmacogenetic
platform for the diagnosis of genetic variants. This aids clinicians to
quickly access key genetic information required to help them make the right
choices for the right medicine to be effective for an individual.
Availability of an individual's genetic information has a range of benefits
including helping address ineffective medication and associated adverse events
and can help better inform medicine selection and dosing, ultimately improving
patient outcomes and reducing healthcare costs. It is estimated that the
cost to the NHS of adverse drug reactions ("ADRs") is £2.2 billion per annum
and that 30 per cent. of ADRs may be preventable by actionable pharmacogenetic
testing.
Generally, pharmacogenetic testing is mainly performed in centralised
laboratories on expensive equipment and cannot address emergency care
requirements where a rapid bedside result in required. In the UK, minimum
result turnaround time from genetic testing hubs is three days with averages
far higher and actionable pharmacogenetic tests in emergency care requires
quicker result availability than laboratory-based testing can currently
provide.
The use of pharmacogenetic testing is gaining pace and the UK is seeing an
expanding number of genetic tests driven by a number of factors including the
national genomic testing directory, licensing of medicines with
pharmacogenetic guided dosing and professional body guidelines and
recommendations for practice. Genomics and diagnostics are therefore key
in the healthcare shift towards personalised medicines to improve patient
outcomes and reducing costs.
Against this market backdrop the Company has developed two flagship tests:
· what the Directors believe to be the world's first genetic test to
help avoid Antibiotic Induced Hearing Loss ("AIHL" or MT-RNR1") in neonates at
the point of care - this test is CE-IVD certified, permitting registration and
sales in those countries recognising CE-IVD); and
· a genetic test for more effective management of stroke patient
treatment ("CYP2C19") - this test is currently UKCA certified, permitting
sales in the UK, and is progressing to CE-IVD certification to permit
registrations and sales in countries recognising CE-IVD.
Both of these tests have been developed in collaboration with NHS partners and
recommended by the National Institute for Health and Care Excellence ("NICE")
for use in the UK NHS. Final guidance for the CYP2C19 test under the NICE
DAP process is expected in July 2024 and a conditional recommendation for the
AIHL test has also been received under the NICE EVA process enabling use in
the NHS whilst further evidence is generated, with a funding decision from
NIHR/OLS to address these gaps at the national level also expected in July
2024.
Having raised over £40 million since Q4 2011 to fund the continued
development of the Genedrive® platform and connected assays genedrive is now
firmly in the commercialisation phase and is pursuing a direct to consumer
strategy in the UK and a focused distributor network elsewhere.
The markets that the Company is targeting are significant relative to its
size. The Company estimates the global overall market opportunity of its
AIHL and CYP2C19 assays is over £300 million per annum.
2. The Company's Assays and Markets
Antibiotic-Induced Hearing Loss ("AIHL")
Ototoxicity from antibiotics is a widely known issue with specific clinical
guidance on genetic mutations and their role in hearing loss in newborns.
Around one in 500 babies carry a genetic mutation that puts them at risk of
suffering lifelong profound hearing loss after exposure to gentamicin, a
commonly used antibiotic. genedrive has developed what is believes to be the
world's first rapid point-of-care genetic test for hearing loss for neonatal
intensive care. Around one in seven babies born in the UK are admitted to
neonatal intensive care units (around 100k per annum) with a significant
proportion requiring treatment with antibiotics, with clinical guidance
requiring antibiotic administration within one hour of a decision to treat
those at risk of sepsis. genedrive's AIHL test, which has been developed in
collaboration with the NHS, takes around 26 minutes to deliver a result and
allows for safer alternative prescriptions in babies with the genetic
mutation, avoiding profound irreversible and lifelong hearing loss potentially
resulting in these individuals following exposure to these antibiotics.
In March 2023, the Genedrive® MT-RNR1-ID Kit received a recommendation for
use in the UK by the NICE under its Early Value Assessment Programme
("EVA"). NICE concluded that the Genedrive® MT-RNR1-ID Kit can quickly and
accurately identify babies with the primary genetic variant, there is
currently no other test available that provides results quickly enough to
inform decisions on antibiotic prescribing in emergency care, the long-term
savings to the NHS associated with hearing loss and fitting cochlear implants
would be substantial and aminoglycoside-induced hearing loss has a major
impact on the quality of life of children and their families.
The EVA was introduced to allow rapid assessment of novel digital products,
devices and diagnostics for clinical effectiveness and value for money, so
that the NHS and patients can benefit from these promising technologies
sooner. The recommendation received is conditional on further evidence being
generated and the Company is a partner with clinical colleagues at Manchester
University NHS Foundation Trust ("MFT") who have recently applied for funding
to address the NICE EVA evidence generation recommendations at national level,
which are required for progressing the NICE conditional recommendation into a
full recommendation at the earliest opportunity. The NIHR i4i & OLS Real
World Evidence Programme, which is intended to address each eligible EVA, is
being led by Office for Life Sciences ("OLS") as part of the UK Government's
Life Sciences Vision and is backed by £10m of government funding and, if
successful, is expected to commence in October 2024.
The Genedrive® MT-RNR1-ID Kit has now been implemented into routine clinical
use in four UK hospitals with several more in local business case planning
phase. genedrive expects a further five UK hospitals progressing to routine
clinical use within four months and a further five in 12 months taking the
total to 14. The Company has been selling direct in the UK since February
2024 and sales ramp up in the UK is expected to be greatly accelerated by
either of two routes: i) NHS specialist commissioning which is expected in
April 2025 and / or (ii) change in NICE guidance from conditional to full.
Through the rest of 2024 genedrive expects commercial progress in nine other
countries across Europe and the Middle East where contracted distributors are
in place and are currently in the in-county pilot phase.
In December 2023, following product registration and language translations for
each country (including user-facing instrument software in addition to
accompanying documentation), the first international sales of the Genedrive®
MT-RNR1 ID Kit were achieved in France, Austria, Greece, Saudi Arabia, Turkey
and the Netherlands and we have recently signed new distributors in Italy and
the UAE.
More recently, on 24 April 2024, the Company announced a Clinical Trial
Agreement with a leading multi-state physician organisation ("Research
Partner") in the USA to support clinical studies required for engagement with
the FDA to progress the regulatory approval of the Genedrive® MT-RNR1 ID Kit
into the USA via the FDA De novo submission process. The U.S. market via an
FDA approval represents a significant upside as in 2021, 3.6 million babies
were born in the United States, with 10% born prematurely (360,000 NICU
admissions). It has been estimated that malpractice litigation settlements in
cases related to deafness caused by the use of aminoglycosides average over
US$1.1 million per case, further adding to the positive health economic case
of providing accurate and timely testing to reduce unwanted side effects of
gentamicin usage.
The FDA De Novo pathway provides a vehicle for establishing new predicate
devices that can reflect modern standards for performance and safety and can
serve as a basis for future clearances. De Novo classification is a risk-based
classification process used when there is a lack of predicate device already
cleared by the FDA. genedrive's partnership enables affordable access for
clinical studies in NICU sites in the U.S. as required for the FDA de novo
submission process, with a leading multi-state physician organisation with
expertise and coverage of U.S. neonatal services in a majority of US states.
The U.S. clinical studies are expected to take
12-18 months from first patient recruitment and the endpoint will be
performance of the Group's test against a validated reference laboratory test
as well as risk/benefit analysis. Regulatory review is expected to take a
year post completion of the clinical studies although this may be expedited
via seeking FDA breakthrough device designation which can expedite the review
process to less than 300 days.
A distributor agreement is in place with International Biomedical, Ltd. to
support the FDA study and future sales in the United States. International
Biomedical, based in Texas USA, has over 45 years' experience in the design,
manufacture and distribution of neonatal and perinatal products and solutions.
The Company estimates that the total addressable UK market is up to £8.5
million per annum which is based on approximately 100,000 NICU admissions per
annum and an estimated customer price per test of more than £80. The EU
market is potentially another c.£46.75 million per annum, the U.S. market is
c.£34 million and rest of World markets around £13.75 million. Market
estimates are based on end user pricing.
Genedrive® CYP2C19-ID Kit ("CYP2C19")
There are over 100,000 strokes per annum in the UK and over 12 million
globally which is predicted to increase 60% by 2035. Quick treatment is
critical to mitigating damage and preventing further strokes and anti-platelet
therapies are usually a key first step in treating stroke patients. A
commonly prescribed antiplatelet drug is clopidogrel with 11 million
prescriptions in England between 2020 and 2021 and it was also ranked 37th in
top drug use in the U.S. in 2021 with 4.2 million patients and 17 million
prescription events.
Clopidogrel is an inactive pro-drug administered for the management of strokes
but it requires conversion to its active form by the enzyme, CYP2C19. The
combination of inherited CYP2C19 alleles determines the individual's
metaboliser status, with circa 30 per cent. of people having variants in the
CYP2C19 gene which results in a sub-optimal response to Clopidogrel and worse
health outcomes for stroke patients. Rapid identification of stroke patients
with variants to the CYP2C19 gene therefore enables them to avoid clopidogrel
and be prescribed an alternative anti-platelet drug. One alternative to
Clopidogrel is Ticagrelor and whilst this is not impacted by CYP2C19 it is
more expensive, has increased bleeding risks and does not have marketing
authorisation for use in preventing further TIA (transient ischaemic attack)
or strokes in the UK.
The Genedrive® CYP2C19 test uses a single, non-invasive cheek swab sample and
within circa 70 minutes can identify six important genetic variants of the
CYP2C19 gene, five of which are "loss of function" variants in which
Clopidogrel response and patient outcome may be impaired. The Genedrive®
system automatically interprets the information for the clinician, allowing
prompt administration of an optimised treatment plan. In its performance
evaluations, the test achieved 100% accuracy in detecting the variants that
underpin loss of metabolism function.
In the UK, the National Institute for Health and Care Excellence ("NICE")
recommended in May 2023 draft guidance that people who have had an ischaemic
stroke or transient ischaemic attack ("TIA") should have a CYP2C19 genetic
test prior to treatment. In April 2024, NICE recommended Genedrive® as the
point-of-care platform of choice for CYP2C19 genotyping strategies in
the NHS. The decision was based on several differentiating features of the
Genedrive® technology; (1) its greater coverage of genetic variants compared
to the other point-of-care system assessed, permitting increased equitable
access to healthcare across ethnic populations, (2) no requirement for
cold-chain storage logistics, and (3) its ability to integrate with patient
electronic healthcare systems.
The Company's ongoing valued long-standing partnership with clinical genetics
collaborators in Manchester under the DEVOTE programme will supplement its
existing clinical performance data used for UKCA certification and lead to
anticipated CE-IVD certification in Q1 2025 and commercialisation (via
distributors) within the European Union as well as additional countries that
recognise CE-IVD. Following the completion of the DEVOTE clinical
performance, together with final NICE recommendation due on 10 July 2024, the
Company would intend to actively pursue commercialisation in the UK itself
targeting all of the stroke hubs / integrated stroke delivery networks.
genedrive also believes there is potential for "research only" sales for
specific non-UK targets in advance of CE-IVD and in-country registrations.
Longer term, in the second half of 2025, genedrive would also seek to commence
an FDA registration process for CYP2C19 to permit future sales in the USA.
The Company estimates that the total addressable UK market is up to £8.5
million per annum, based on the assumption that there are over 100,000 strokes
per annum and an estimated customer price per test of approximately £100. The
EU market is estimated to be c.£93.5 million, the U.S. market is c.£67.6
million and rest of the world markets approximately £51 million. Market
estimates are based on end user pricing.
3. Future News Flow
With the Fundraising being used to underpin and grow the Group's operations
and accelerate commercialisation throughout the UK, Europe and the Middle
East, in the near term the Group expects to drive revenues for the MT RNR1
test from additional go-live sites in the UK and abroad and will also start
sales and marketing activity in the UK for the CYP2C19 test as well as
pursuing research use only sales outside of the UK. In addition the Group
expects to make continued progress in the near term with special commissioning
for the MT-RNR1 test and also finalise the position with the FDA for
registration requirements with for the MT-RNR1 test. NICE's final
recommendation for the CYP2C19 test is expected on 10 July 2024 and the DEVOTE
clinical study (also for CYP2C19) is progressing and once this has completed
the Group expects to make a CE-IVD submission in H2 2024 with certification
anticipated in early 2025.
In the medium to longer term the Group expects to launch CYP2C19 on the back
of CE-IVD certification (anticipated in early 2025) and commence FDA
registration studies for its MT-RNR1 test in conjunction with its recently
announced research partner. Work will also be undertaken on assessing the
business case for future pipeline targets. Finally, in the second half of
2025, genedrive would also look to commence an FDA registration process for
MT-RNR1.
4. Current Trading and Outlook post the Fundraising
The Company issued its unaudited interim results for the six months to 31
December 2023 on 28 March 2024. Unaudited revenues and other income in the
six months to 31 December 2023 were £0.24 million and the operating loss was
£2.4 million. Period end cash was £1.2 million. The unaudited cash
balance on 21 March 2024 was £1.2 million with £0.8 million received from
the R&D tax credit post period end and at the Company's current burn rate
it has a cash runway through May 2024 (pre the Fundraising).
The Board's internal assumptions of revenue growth forecast the Company
transitioning to a positive EBITDA position in the second half the financial
year ending 30 June 2026. The Group's operating expenses are expected to
ramp up to circa £0.65m per month during calendar year 2025 as it funds
various growth initiatives.
5. Use of Proceeds
The net proceeds of the Fundraising (assuming the Minimum Proceeds are raised)
are expected to be used as follows.
Approximately 70 per cent. will go towards the following:
· Business development, marketing and support team expansion in the UK,
EU and the Middle East increasing the commercial team headcount from seven to
eleven
· Pursuing a direct sales model in the U.K. for the MT-RNR1 ID kits
· Marketing, PR, promotions, tradeshows and digital sales channels
· Roll out of the CYP2C19 test in the UK following completion of DEVOTE
study and facilitated by final NICE guidance due to be published in July 2024
· Internalisation of manufacturing to permit more efficient scale up of
assays as well as onshoring and increased production of instrumentation; and
· Building EU and Middle Eastern distribution network for the Group's
CYP2C19 ID kit product following CE-IVD and in country registration process.
Approximately 20 per cent. will go towards U.S. regulatory activities and
mid-term product development as detailed below:
· FDA submission process for the MT-RNR1 ID kit test to position for
registration and commercialisation in the U.S.;
· Assessing the regulatory pathway and other requirements for potential
FDA approval of the CYP2C19 assay;
· Instrumentation enhancements to further facilitate user experience
and adoption; and
· Developing version 2 of MT-RNR1 ID kit to include two additional
high-risk variants.
Finally, approximately 10 per cent. will go towards the Group's working
capital and funding general corporate purposes.
The net proceeds of the Firm Placing will only provide some very short-term
working capital for the Company.
The proceeds of the Placing (before expenses) are expected to raise
approximately £2.5 million and the proceeds of the REX Offer (before
expenses) could be up to approximately £3.5 million and the proceeds of the
Open Offer (before expenses) could be up to approximately £2.1 million.
The Open Offer is being made for up to 143,141,481 Open Offer Shares at the
Issue Price on the basis of 1 Open Offer Share for every 1 Ordinary Share held
by Qualifying Shareholders at the Record Date, to raise up to approximately
£2.1 million before expenses. Shareholders subscribing for their full
entitlement under the Open Offer may also apply for additional Open Offer
Shares under the Excess Application Facility, up to the total number of Open
Offer Shares available to Qualifying Shareholders under the Open Offer.
The Directors have also separately evaluated various funding options. The
Directors have given careful consideration to the structure of the Fundraising
and concluded that the Placing, together with the REX Offer and the Open
Offer, was the most suitable option available to the Company and its
Shareholders at this time and also provide the highest chance of raising the
Minimum Proceeds.
All of the Company's Directors intend to participate in the Fundraising either
via the Placing, the REX Offer or the Open Offer. The £ sterling amount
they each intend to subscribe for is as follows: James Cheek - £10,000, Russ
Shaw - £25,500, Gino Miele - £9,000, Ian Gilham £10,000, Tom Lindsay -
£10,000 and Chris Yates - £3,000.
Principal Terms of the Placing
Peel Hunt as agent for the Company, has agreed to use its reasonable
endeavours to procure Placees by way of an accelerated bookbuild process on
the terms of the Placing and Open Offer Agreement. Placees are required to
subscribe for the Placing Shares on the basis of the Terms and Conditions of
the Placing set out in Appendix II to this Announcement. None of the Placing,
the REX Offer or the Open Offer is being underwritten.
The issue of the Placing Shares is intended to raise approximately £2.5
million (before expenses). If the REX Offer and the Open Offer are taken up
in full, the Company would raise a further approximately £5.6 million (before
expenses). Details of the number of Placing Shares to be issued will be
announced as soon as practicable after the close of the Bookbuild.
Under the Placing and Open Offer Agreement, the Company has agreed to pay to
Peel Hunt commission based on the aggregate value of the New Ordinary Shares
placed under the Placing and issued under the REX Offer and the Open Offer at
the Issue Price and the costs and expenses incurred in relation to the Placing
and Open Offer together with any applicable VAT.
No commissions will be paid to Placees or by Placees in respect of any New
Ordinary Shares.
The Firm Placing may complete even if the Conditional Placing does not,
whether by reason of a failure to obtain Shareholder approval or
non-satisfaction of the other conditions including the Company not raising the
Minimum Proceeds. If this eventuality was to arise, the Company will not
receive any proceeds of the Conditional Placing and its cash runway will
remain extremely limited, it will only have around seven weeks of working
capital and the Company would urgently need to seek further financing which
may or may not be available at all or, if available, may be on commercially
unacceptable terms and could lead to more substantial dilution for
Shareholders than would be the case under the proposed Fundraise.
Subject to the discretion of the Company and Peel Hunt to elect otherwise, the
Firm Placing Shares and the Conditional Placing Shares will be allocated
proportionately with the same investors. An investor allocated Firm Placing
Shares will be conditionally allocated an equivalent proportion of Conditional
Placing Shares.
The Firm Placing is conditional upon, among other things, the Placing and Open
Offer Agreement not being terminated in accordance with its terms before First
Admission and the Conditional Placing is conditional upon, among other things,
the Placing and Open Offer Agreement not being terminated in accordance with
its terms before Second Admission.
The Placing Shares, when issued, will be credited as fully paid and will be
identical and rank pari passu in all respects with the Company's then existing
Shares, including the right to receive all dividends and other distributions
declared, made or paid on or in respect of such shares after the relevant date
of issue of the First Placing Shares and the Second Placing Shares.
Conditionality
The Conditional Placing and Open Offer are conditional, amongst other things,
upon the following:
· the Minimum Proceeds being raised;
· the passing, without amendment, of Resolutions 1 and 2 at the
General Meeting;
· none of the warranties contained in the Placing and Open
Offer Agreement, in the opinion of Peel Hunt (acting in good faith), being
untrue or inaccurate or misleading at the date of the Placing and Open Offer
Agreement or becoming untrue or inaccurate or misleading at any time between
such date and Second Admission by reference to the facts and circumstances
from time to time subsisting;
· the Company having complied with all of its obligations under
the Placing and Open Offer Agreement which fall to be performed or satisfied
on or prior to First Admission or Second Admission; and
· Second Admission occurring by no later than 8.00 a.m. on 3 June
2024 (or such later time and/or date as may be agreed between the Company and
Peel Hunt), being no later than 8.00 a.m. on 17 June 2024.
If the conditions set out above are not satisfied or waived (where capable of
waiver), the Conditional Placing and the Open Offer will lapse and the
Conditional Placing Shares and the Open Offer Shares will not be allotted and
issued and no monies will be received by the Company in respect of those
elements of the Fundraising.
The Firm Placing is not conditional on the passing of the Resolutions at the
General Meeting nor on completion of the Conditional Placing, the REX Offer or
the Open Offer. It is also not conditional on the Minimum Proceeds being
raised. It is expected that the Firm Placing Shares will be admitted to
trading on AIM on 15 May 2024, the expected date of First Admission.
Effect of the Placing
The New Ordinary Shares will, following the relevant Admission, be identical
to and rank pari passu in all respects with the Existing Ordinary Shares in
issue at the date of this Announcement and will carry the right to receive all
dividends and distributions declared, made or paid on or in respect of the
Ordinary Shares after First Admission, in respect of the Firm Placing Shares,
and after Second Admission in respect of the Conditional Placing Shares.
Since the Company entered into an equity prepayment facility of up to £5
million with Riverfort Global Opportunities PCC Limited ("Riverfort") on 31
March 2023, a total of 8,616,321 warrants to subscribe for Ordinary Shares in
the Company have been issued to Riverfort with exercise prices between 41.6p
and 10.4p. Under the terms of the warrant instrument, the exercise price of
these warrants will be reduced to the Issue Price upon First Admission.
6. The Placing and Open Offer Agreement
Pursuant to the terms of the Placing and Open Offer Agreement, Peel Hunt, as
agent for the Company, has agreed to use its reasonable endeavours to procure
Placees to take up the Placing Shares on the terms and subject to the
conditions set out therein, at the Issue Price. The Placing and Open Offer
Agreement is conditional upon, amongst other things, the conditions set out
above.
The Placing and Open Offer Agreement contains customary warranties given by
the Company in favour of Peel Hunt in relation to, amongst other things, the
accuracy of the information in this Announcement and other matters relating to
the Group and its business. In addition, the Company has agreed to indemnify
Peel Hunt (and its affiliates) in relation to certain liabilities which they
may incur in respect of the Placing.
Peel Hunt has the right to terminate its obligations under the Placing and
Open Offer Agreement in certain circumstances prior to Admission. In
particular, in the event of breach of the warranties or a material adverse
change or if the Placing and Open Offer Agreement does not become
unconditional where Peel Hunt terminates its obligations under the Placing and
Open Offer Agreement, the Placing and Open Offer Agreement will cease and
terminate.
7) General Meeting
Whilst the Directors have authority to issue the Firm Placing Shares they do
not currently have authority to allot the Conditional Placing Shares, the REX
Offer Shares and the Open Offer Shares and, accordingly, the Board is seeking
the approval of Shareholders, at the General Meeting, to allot the Conditional
Placing Shares, the REX Offer Shares and the Open Offer Shares. A circular
will be posted to shareholders in connection with the General Meeting shortly.
The General Meeting is being held inter alia for the purpose of considering
and, if thought fit, passing the Resolutions in order to approve the
authorities required to allot and issue the Conditional Placing Shares and the
Open Offer Shares. The approval of Shareholders is also being sought to renew
the Directors' general authority to allot shares and disapply pre-emption
rights which was granted at the AGM on 29 December 2023, and which will be
used to allot and issue the Firm Placing Shares.
Shareholders are reminded that the Conditional Placing, the REX Offer and the
Open Offer are conditional, inter alia, on the passing of Resolutions 1 and 2
to be proposed at the General Meeting. Should the Resolutions not be passed,
those elements of the Fundraising will not proceed and any associated monies
in respect of the Conditional Placing Shares, the REX Offer and Open Offer
Shares will be returned to investors. Further, in the event that the Minimum
Proceeds are not raised any associated monies in respect of the Conditional
Placing Shares, the REX Offer and Open Offer Shares will be returned to
investors Should that situation arise yet the Company still receives the
net proceeds of the Firm Placing, it will only have around seven weeks of
working capital and therefore the Directors would need to urgently explore
alternative forms of funding for its operations which may not be available at
all or, if available, may be on commercially unacceptable terms and could lead
to more substantial dilution for Shareholders than would be the case under the
proposed Placing, REX Offer and Open Offer.
8) Admission
Applications will be made to the London Stock Exchange for (i) admission of
the Firm Placing Shares to trading on AIM ("First Admission") and (ii)
admission of the Conditional Placing Shares and such number of REX Offer
Shares and Open Offer Shares as are subscribed for under the, REX Offer and
the Open Offer to trading on AIM ("Second Admission" and together with First
Admission, "Admission"). It is expected that First Admission will become
effective at or around 8.00 a.m. on 15 May 2024 or such later time and date
(being not later than 8.00 a.m. on 29 May 2024) and the Second Admission will
become effective at or around 8.00 a.m. on 3 June 2024 or such later time and
date (being not later than 8.00 a.m. on 17 June 2024), in each case as Peel
Hunt and the Company may agree.
9) Recommendation
The Directors consider that the Fundraising and the passing of the Resolutions
are in the best interests of the Company and its Shareholders as a whole.
Accordingly, the Directors unanimously recommend that Shareholders vote in
favour of all of the Resolutions, as they intend to do in respect of their
beneficial holdings of an aggregate of 1,011,545 Existing Ordinary Shares,
representing approximately 0.7 per cent. of the Existing Ordinary Shares.
10) Risk Factors
Clinical, Regulatory and reimbursement risks
The Group's point of care diagnostic instruments and tests are subject to
regulation in every jurisdiction in which they are sold. Further, whilst the
Group has already received certain approvals and/or accreditations to market
its products in certain jurisdictions its future commercialization plans
require the receipt of further approvals, endorsements and/or accreditations
for certain of its products including, for example, obtaining final
recommendations from NICE for its CYP2C19 genetic test in the UK and CE-IVD
registration for the same test which would permit the marketing of the test in
countries that recognise CE-IVD regulatory approvals. The Group's strategy and
future commercial success relies in part on regulatory approvals for its
instruments and tests as well as availability of funds from healthcare
systems, Government and other organisations to fund their use.
Changes in either the content or timetable of regulatory requirements or the
process for obtaining approvals, endorsements and/or accreditations and
changes or restrictions in the availability of Government or other funding
could adversely affect the timing or level of related product sales which will
likely adversely impact its financial performance and prospects. Should it be
the case that the Group's products become subject to further regulatory or
other restrictions, then the Group may incur further research and/or
development costs, could be required to apply for regulatory approvals, that
could have a material adverse effect on its financial position or prospects,
or may not meet new approval/accreditation standards.
The Group intends to allocate a proportion of the net proceeds from the
Fundraising to commence FDA registration studies in the U.S. for its MT-RNR1
test. Failure or delay in completing the required clinical studies for this
test, which could be caused by a wide variety of reasons, may prevent it from
obtaining regulatory approval or being commercialised in the U.S. market which
could require the Company to incur additional costs and could delay or
eliminate receipt of product revenue from this test. Further, the Company's
clinical trial agreement with a leading multi-state physician organisation may
not provide the expected level of support for the Company in conducting these
studies which may increase the costs and timelines that the Group expects
these studies to take.
Even if the Company is able to complete the necessary clinical studies in the
U.S. it cannot predict when or if it will obtain FDA approval to commercialise
its MT-RNR1 product to permit it to be commercialised or if any condition
attached to such approval may be more stringent than the Company currently
expects.
The same risks and uncertainties around undertaking U.S. clinical trials for
the MT-RNR1 product will also apply to the Group's CYP2C19 product should the
Company ultimately commence clinical trials for this product in that
territory.
Financial position
The Group has historically been loss making and its future capital needs are
uncertain and will be influenced by a wide range of factors including the rate
at which the Company may be able to grow its product sales in the future and
accordingly there can be no assurance that the Company will not need to raise
additional funds in the future. Further, there can be no certainty when, or
if, the Group will achieve profitability or positive operating cash flow and
the Group cannot be certain of its future financing needs or that suitable
financing will be available in the required amounts or on acceptable terms.
The Group's future capital needs, and other business reasons at that time, may
require the Company to issue additional equity or obtain a credit facility. If
additional equity or equity-linked securities were to be issued this may
result in the dilution of existing shareholders' holdings. The incurrence of
indebtedness would result in debt service obligations and could result in
operating and financing covenants that would restrict the Group's operations.
The failure to raise such funds or sufficient funds means the Group could
continue to have going concern challenges until it builds a portfolio of
profitable diagnostic assays.
Competitors
Competitors may develop or launch products which have the same or better
functionality and characteristics and target similar health challenges which
will compete with the Group's products. The Company also operates in the
diagnostics sector which has a large number of companies with significantly
more scale and resources than the Company has as its disposal, the Company may
not be able to compete effectively against such organisations should they seek
to compete against the Company in its chosen markets. Loss of first-to-market
advantage or reduction in market share to a competitor could have a material
adverse effect on the Group's financial position or prospects.
Dependency on distribution partners for revenue generation
The Group uses, in certain jurisdictions, an indirect sales model whereby
distributors, agents and other channel partners sell the Company's products.
There are risks in this model because the Group does not control the pricing
of its products and services and relies on the skills of partners' sales teams
to generate revenue. The Group cannot ensure that it will be able to retain
its distributors, renew existing distribution agreements on commercially
favourable terms, enter into new distribution agreements for target
geographical markets or that distribution partners will dedicate the resources
necessary for the commercial success of the Group's products.
Dependency on key suppliers
The manufacture of the Group's products involves a number of raw materials and
components, some of which may only be available from a limited number of third
parties. Failure by a third party to deliver raw materials or components or a
third party ceasing to manufacture components, competition for or other
restriction on the availability or timing or supplies could result in delays
in the manufacture of products or the need to redesign certain elements. Such
an event could have an adverse impact on the revenues and profitability of the
Group and its ability to manufacture certain products and diagnostic assays.
Direct selling model
The Group's products to date have largely been marketed via an indirect sales
model whereby distributors, agents and other channel partners sell the
Company's products in certain jurisdictions. The Company has a limited track
record in establishing and operating successfully a direct sales team. Any
delay in recruiting, training or otherwise establishing an effective direct
sale team for any of the Company's products, including the MT-RNR1 test, and
the CYP2C19 test could have an adverse impact on the Company's revenues.
Management of the Group's business strategy
There can be no certainty that the Group will be able to implement
successfully its stated strategy. The ability of the Group to implement its
strategy in rapidly evolving and competitive markets will require effective
management planning and operational controls.
If the Company is unable to implement its business strategy it could have a
material adverse effect on its financial position or prospects.
Dependence on key executives and personnel
The Group's development and prospects are dependent upon training and
retaining qualified professional, scientific and technical operating staff.
Whilst the Group has entered into contractual arrangements with these
individuals with the aim of securing the services of each of them, retention
of these services cannot be guaranteed and the loss of the services of any of
the Directors, senior management or key personnel may have a material adverse
effect on the Group and its commercial and financial performance, and damage
the value of an investment in the Ordinary Shares.
APPENDIX II - TERMS AND CONDITIONS OF THE PLACING
IMPORTANT INFORMATION ON THE PLACING FOR INVITED PLACEES ONLY.
MEMBERS OF THE PUBLIC ARE NOT ELIGIBLE TO TAKE PART IN THE PLACING. THIS
ANNOUNCEMENT, INCLUDING THIS APPENDIX AND THE TERMS AND CONDITIONS SET OUT
HEREIN (TOGETHER, THIS "ANNOUNCEMENT") (WHICH IS FOR INFORMATION PURPOSES
ONLY) IS DIRECTED ONLY AT: (A) PERSONS IN A MEMBER STATE OF THE EUROPEAN
ECONOMIC AREA (THE "EEA") WHO, ARE "QUALIFIED INVESTORS" WITHIN THE MEANING OF
ARTICLE 2(E) OF REGULATION (EU) NO 2017/1129, AS AMENDED FROM TIME TO TIME
(THE "EU PROSPECTUS REGULATION") ("QUALIFIED INVESTORS"); AND (B) PERSONS IN
THE UNITED KINGDOM WHO ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE
2(E) OF THE UK VERSION OF REGULATION (EU) 2017/1129 , AS AMENDED FROM TIME TO
TIME AND AS RETAINED AS PART OF UK LAW BY VIRTUE OF THE EUROPEAN UNION
(WITHDRAWAL) ACT 2018) (THE "EUWA") (THE "UK PROSPECTUS REGULATION") WHO ARE
PERSONS WHO (I) HAVE PROFESSIONAL EXPERIENCE IN MATTERS RELATING TO
INVESTMENTS WHO FALL WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND
MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (AS AMENDED) (THE "ORDER")
(INVESTMENT PROFESSIONALS); (II) ARE PERSONS FALLING WITHIN ARTICLE 49(2)(A)
TO (D) ("HIGH NET WORTH COMPANIES, UNINCORPORATED ASSOCIATIONS, ETC") OF THE
ORDER; OR (III) ARE PERSONS TO WHOM IT MAY OTHERWISE BE LAWFULLY COMMUNICATED
(ALL SUCH PERSONS TOGETHER BEING REFERRED TO AS "RELEVANT PERSONS").
THIS ANNOUNCEMENT AND THE INFORMATION IN IT MUST NOT BE ACTED ON OR RELIED ON
BY PERSONS WHO ARE NOT RELEVANT PERSONS. PERSONS DISTRIBUTING THIS
ANNOUNCEMENT MUST SATISFY THEMSELVES THAT IT IS LAWFUL TO DO SO. ANY
INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS
AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT
PERSONS. THIS ANNOUNCEMENT DOES NOT ITSELF CONSTITUTE AN OFFER FOR THE SALE OR
SUBSCRIPTION OF ANY SECURITIES IN THE COMPANY.
The Placing Shares have not been and will not be registered under the U.S.
Securities Act of 1933, as amended (the "US Securities Act") or under any
securities laws of any state or other jurisdiction of the United States and
may not be offered, sold, resold, transferred or delivered, directly or
indirectly, in or into the United States except pursuant to an applicable
exemption from the registration requirements of the US Securities Act and in
compliance with the securities laws of any state or other jurisdiction of the
United States. There will be no public offer of the securities mentioned
herein in the United States.
This Announcement and the information contained herein is restricted and is
not for release, publication or distribution, in whole or in part, directly or
indirectly, in or into or from the United States, Australia, Canada, Japan,
the Republic of South Africa or any other jurisdiction in which such release,
publication or distribution would be unlawful.
Each Placee should consult with its own advisers as to legal, tax, business
and related aspects of a purchase of Placing Shares.
The distribution of this Announcement and/or the Placing and/or the issue of
the Placing Shares in certain jurisdictions may be restricted by law. No
action has been taken by the Company, the Bookrunner or any of their
respective affiliates, agents, directors, officers or employees that would
permit an offer of the Placing Shares or possession or distribution of this
Announcement or any other offering or publicity material relating to such
Placing Shares in any jurisdiction where action for that purpose is required.
Persons into whose possession this Announcement comes are required by the
Company and the Bookrunner to inform themselves about and to observe any such
restrictions.
This Announcement or any part of it does not constitute or form part of any
offer to issue or sell, or the solicitation of an offer to acquire, purchase
or subscribe for any securities in the United States, Australia, Canada, Japan
or the Republic of South Africa or any other jurisdiction in which the same
would be unlawful. No public offering of the Placing Shares is being made in
any such jurisdiction.
The relevant clearances have not been, nor will they be, obtained from the
securities commission of any province or territory of Canada, no prospectus
has been lodged with, or registered by, the Australian Securities and
Investments Commission or the Japanese Ministry of Finance; the relevant
clearances have not been, and will not be, obtained for the South Africa
Reserve Bank or any other applicable body in the Republic of South Africa in
relation to the Placing Shares and the Placing Shares have not been, nor will
they be registered under or offered in compliance with the securities laws of
any state, province or territory of Australia, Canada, Japan or the Republic
of South Africa. Accordingly, the Placing Shares may not (unless an exemption
under the relevant securities laws is applicable) be offered, sold, resold or
delivered, directly or indirectly, in or into Australia, Canada, Japan or the
Republic of South Africa or any other jurisdiction outside the EEA or the
United Kingdom.
Persons (including without limitation, nominees and trustees) who have a
contractual right or other legal obligations to forward a copy of this
Announcement should seek appropriate advice before taking any action.
This Announcement should be read in its entirety. In particular, you should
read and understand the information provided in the "Important Notice" section
of this Announcement.
By participating in the Bookbuild and/or the Placing, each Placee will be
deemed to have read and understood this Announcement in its entirety, to be
participating, making an offer and acquiring Placing Shares on the terms and
conditions contained herein and to be providing the representations,
warranties, indemnities, acknowledgements and undertakings contained in this
Appendix.
In particular, each such Placee represents, warrants, undertakes, agrees and
acknowledges (amongst other things) that:
1. it is a Relevant Person and undertakes that it
will acquire, hold, manage or dispose of any Placing Shares that are allocated
to it for the purposes of its business;
2. in the case of a Relevant Person in the United
Kingdom who acquires any Placing Shares pursuant to the Placing:
(a) it is a Qualified Investor within the
meaning of Article 2(e) of the UK Prospectus Regulation; and
(b) in the case of any Placing Shares
acquired by it as a financial intermediary, as that term is used in Article
5(1) of the UK Prospectus Regulation:
(i) the Placing Shares acquired by it in the
Placing have not been acquired on behalf of, nor have they been acquired with
a view to their offer or resale to, persons in the United Kingdom other than
Qualified Investors or in circumstances in which the prior consent of the
Bookrunner has been given to the offer or resale; or
(ii) where Placing Shares have been acquired by it
on behalf of persons in the United Kingdom other than Qualified Investors, the
offer of those Placing Shares to it is not treated under the UK Prospectus
Regulation as having been made to such persons;
3. in the case of a Relevant Person in a member
state of the EEA which has implemented the EU Prospectus Regulation (each, a
"Relevant Member State") who acquires any Placing Shares pursuant to the
Placing:
(a) it is a Qualified Investor within the meaning
of Article 2(e) of the EU Prospectus Regulation; and
(b) in the case of any Placing Shares acquired by
it as a financial intermediary, as that term is used in Article 5(1) of the
EU Prospectus Regulation:
(i) the Placing Shares acquired by it in the Placing have
not been acquired on behalf of, nor have they been acquired with a view to
their offer or resale to, persons in any Relevant Member State other than
Qualified Investors or in circumstances in which the prior consent of the
Bookrunner has been given to the offer or resale; and
(ii) where Placing Shares have been acquired by it on behalf
of persons in any Relevant Member State other than Qualified Investors, the
offer of those Placing Shares to it is not treated under the EU Prospectus
Regulation as having been made to such persons;
4. it is acquiring the Placing Shares for its own
account or is acquiring the Placing Shares for an account with respect to
which it has authority to exercise, and is exercising, investment discretion
and has the authority to make and does make the representations, warranties,
indemnities, acknowledgements, undertakings and agreements contained in this
Announcement;
5. it understands (or if acting for the account of
another person, such person has confirmed that such person understands) the
resale and transfer restrictions set out in this Appendix;
6. except as otherwise permitted by the Company
and subject to any available exemptions from applicable securities laws, it
(and any person on whose account it is acting, as referred to in paragraph 5
above) is located outside the United States and is acquiring the Placing
Shares in an "offshore transaction" as defined in, and in accordance with,
Regulation S under the US Securities Act ("Regulation S"); and
7. it has not offered, sold or delivered and will
not offer to sell or deliver any of the Placing Shares to persons within the
United States, directly or indirectly; neither it, its affiliates, nor any
persons acting on its behalf, have engaged or will engage in any directed
selling efforts (as defined in Regulation S) with respect to the Placing
Shares; and it is not taking up the Placing Shares for resale in or into the
United States.
No prospectus
The Placing Shares are being offered to a limited number of specifically
invited persons only and the Placing Shares will not be offered in such a way
as to require any prospectus or other offering document to be published. No
prospectus or other offering document has been or will be submitted to be
approved by the FCA or any other regulatory authority in relation to the
Placing or the Placing Shares and Placees' commitments will be made solely on
the basis of their own assessment of the Company, the Placing Shares and the
Placing based on the information contained in this Announcement, the
announcement of the results of the Placing (the "Placing Results
Announcement") (together, the "Placing Documents") and any other information
publicly announced through a regulatory information service ("RIS") by or on
behalf of the Company on or prior to the date of this Announcement (the
"Publicly Available Information") and subject to any further terms set forth
in the contract note sent to individual Placees.
Each Placee, by participating in the Placing, agrees that the content of the
Placing Documents is exclusively the responsibility of the Company and
confirms that it has neither received nor relied on any information (other
than the Publicly Available Information), representation, warranty, or
statement made by or on behalf of the Bookrunner or the Company or any other
person and none of the Bookrunner, the Company nor any other person acting on
such person's behalf nor any of their respective affiliates has or shall have
any responsibility or liability for any Placee's decision to participate in
the Placing based on any other information, representation, warranty or
statement. Each Placee acknowledges and agrees that it has relied on its own
investigation of the business, financial or other position of the Company in
accepting a participation in the Placing. No Placee should consider any
information in this Announcement to be legal, tax or business advice. Each
Placee should consult its own attorney, tax adviser and business adviser for
legal, tax and business advice regarding an investment in the Placing Shares.
Nothing in this paragraph shall exclude the liability of any person for
fraudulent misrepresentation.
Details of the Placing and Open Offer Agreement and the New Ordinary Shares
The Bookrunner is acting as bookrunner in connection with the Placing and has
today entered into the Placing and Open Offer Agreement with the Company under
which, on the terms and subject to the conditions set out in the Placing and
Open Offer Agreement, the Bookrunner, as agent for and on behalf of the
Company, has agreed to use its reasonable endeavours to procure placees for
approximately 166,666,667 new Ordinary Shares (the "Placing Shares"). The
Placing will comprise a firm Placing (the "Firm Placing") of up to 11,173,994
Placing Shares (the "Firm Placing Shares") and a conditional Placing (the
"Conditional Placing") of approximately 155,492,673 Placing Shares (the
"Conditional Placing Shares"). The Firm Placing is not conditional on (i) the
passing of any resolutions at the General Meeting, (ii) completion of the
Conditional Placing (and the Firm Placing Shares will be issued using the
authorities granted to the Directors at the annual general meeting of the
Company held on 29 December 2023 or (iii) the Minimum Proceeds being raised.
The Conditional Placing is subject to and conditional on, inter alia, the
passing of resolutions at the General Meeting.
If the Firm Placing completes but the Conditional Placing does not complete,
Placees will still be required to complete the Firm Placing in accordance with
these Terms & Conditions and no sums in respect of the Firm Placing Shares
will be returned to Placees.
The final number of Placing Shares (and the number of Firm Placing Shares and
Conditional Placing Shares) will be set out in a share placing supplement
agreed between the Bookrunner and the Company following the Bookbuild (the
"Placing Supplement"). The allocation of Firm Placing Shares and Conditional
Placing Shares shall be determined by the Bookrunner after consultation with
the Company but it is expected Placees will be allocated the same proportion
of Firm Placing Shares and Conditional Placing Shares. The price payable by
Placees will be 1.5 pence per New Ordinary Share (the "Issue Price").
The Company will also conduct an open offer of up to 143,141,481 new Ordinary
Shares (the "Open Offer Shares") to Qualifying Shareholders at the Issue Price
pursuant to the Open Offer. Additionally, the Company will undertake a retail
offer of up to 233,333,333 new Ordinary Shares (the "REX Retail Offer Shares",
and together with the Placing Shares and the Open Offer Shares, the "New
Ordinary Shares"). Neither the Placing, the Open Offer nor the REX Retail
Offer are being underwritten by the Bookrunner.
The New Ordinary Shares will, when issued, be credited as fully paid up and
will be issued subject to the Company's articles of association and rank pari
passu in all respects with the existing Ordinary Shares, including the right
to receive all dividends and other distributions declared, made or paid on or
in respect of the Ordinary Shares after the date of issue of the New Ordinary
Shares, and will on issue be free of all claims, liens, charges, encumbrances
and equities.
Application for admission to trading
Application will be made to the London Stock Exchange plc (the "London Stock
Exchange") for the admission of the New Ordinary Shares to trading on AIM
(together, "Admission").
It is expected that Admission of the Firm Placing Shares will occur at or
before 8.00 a.m. (London time) on 15 May 2024 (or such later time and/or date
as the Bookrunner may agree with the Company being no later than 8.00 a.m. on
29 May 2024) and that dealings in the Firm Placing Shares will commence at
that time.
It is expected that Admission of the Conditional Placing Shares and the Open
Offer Shares will occur at or before 8.00 a.m. (London time) on 3 June 2024
(or such later time and/or date as the Bookrunner may agree with the Company
being no later than 8.00 a.m. on 17 June 2024) and that dealings in the
Conditional Placing Shares and the Open Offer Shares will commence at that
time.
Bookbuild
The Bookrunner will today commence the accelerated bookbuilding process to
determine demand for Placing Shares by Placees (the "Bookbuild"). This
Announcement gives details of the terms and conditions of, and the mechanics
of participation in, the Placing. No commissions will be paid to Placees or by
Placees in respect of any Placing Shares.
The Bookrunner shall be entitled to effect the Placing by such alternative
method to the Bookbuild as it may, in its absolute discretion following
consultation with the Company, determine.
Participation in, and principal terms of, the Placing
1. The Bookrunner is arranging the Placing as
bookrunner and placing agent of the Company. Participation in the Placing will
only be available to persons who may lawfully be, and are, invited to
participate by the Bookrunner. The Bookrunner may itself agree to be a Placee
in respect of all or some of the Placing Shares or may nominate any member of
its group to do so.
2. The number of Placing Shares will be agreed by
the Bookrunner (in consultation with the Company) following completion of the
Bookbuild. Subject to the execution of the Placing Supplement, the number of
Placing Shares to be issued will be announced on an RIS following the
completion of the Bookbuild via the Placing Results Announcement.
3. Allocations of the Placing Shares will be
determined by the Bookrunner after consultation with the Company (the proposed
allocations having been supplied by the Bookrunner to the Company in advance
of such consultation). Subject to the execution of the Placing Supplement,
allocations in respect of Placing Shares will be confirmed orally by the
Bookrunner and a contract note will be despatched as soon as possible
thereafter. The Bookrunner's oral confirmation to such Placee constitutes an
irrevocable legally binding commitment upon such person (who will at that
point become a Placee), in favour of the Bookrunner and the Company, to
acquire the number of Placing Shares allocated to it and to pay the Issue
Price in respect of such shares on the terms and conditions set out in this
Appendix and in accordance with the Company's articles of association. Except
with the Bookrunner's consent, such commitment will not be capable of
variation or revocation after the time at which it is submitted.
4. Each Placee's allocation and commitment will be
evidenced by a contract note issued to such Placee by the Bookrunner. The
terms of this Appendix will be deemed incorporated in that contract note.
5. Irrespective of the time at which a Placee's
allocation pursuant to the Placing is confirmed, settlement for all Firm
Placing Shares to be subscribed for pursuant to the Placing will be required
to be made at the same time and settlement for all Conditional Placing Shares
to be subscribed for pursuant to the Placing will be required to be made at
the same time, in each case on the basis explained below under "Registration
and Settlement".
6. All obligations under the Bookbuild and/or the
Placing will be subject to fulfilment or (where applicable) waiver of the
conditions referred to below under "Conditions of the Firm Placing" and
"Conditions of the Conditional Placing" (as applicable) and to the Placing not
being terminated on the basis referred to below under "Right to terminate
under the Placing and Open Offer Agreement - Firm Placing" and "Right to
terminate under the Placing and Open Offer Agreement - Conditional Placing"
(as applicable).
7. By participating in the Placing, each Placee
agrees that its rights and obligations in respect of the Placing will
terminate only in the circumstances described below and will not be capable of
rescission or termination by the Placee.
8. To the fullest extent permissible by law,
neither the Bookrunner, nor the Company, nor any of their respective
affiliates, agents, directors, officers or employees shall have any
responsibility or liability to Placees (or to any other person whether acting
on behalf of a Placee or otherwise). In particular, none of the Bookrunner,
nor the Company, nor any of their respective affiliates, agents, directors,
officers or employees shall have any responsibility or liability (including,
to the extent permissible by law, any fiduciary duties) in respect of the
Bookrunner's conduct of the Placing or of such alternative method of effecting
the Placing as the Bookrunner and the Company may determine.
9. The Placing Shares will be issued subject to
the terms and conditions of this Announcement and each Placee's commitment to
subscribe for Placing Shares on the terms set out herein will continue
notwithstanding any amendment that may in future be made to the terms and
conditions of the Placing and Placees will have no right to be consulted or
require that their consent be obtained with respect to the Company's or the
Bookrunner's conduct of the Placing.
10. All times and dates in this Announcement may be
subject to amendment. The Bookrunner shall notify the Placees and any person
acting on behalf of the Placees of any changes.
Conditions of the Firm Placing
The Firm Placing is conditional upon the Placing and Open Offer Agreement
becoming unconditional in respect of the Firm Placing and not having been
terminated in accordance with its terms. The Bookrunner's obligations in
respect of the Firm Placing under the Placing and Open Offer Agreement are
conditional on customary conditions (the "Firm Placing Conditions") including
(amongst others):
1. certain announcement obligations;
2. Admission of the Firm Placing Shares occurring
no later than 8.00 a.m. (London time) on 15 May 2024 (or such later time
and/or date, not being later than 8.00 a.m. (London time) on 29 May 2024 as
the Bookrunner may otherwise agree with the Company);
3. none of the warranties contained in the Placing
and Open Offer Agreement, in the opinion of the Bookrunner (acting in good
faith), being untrue or inaccurate or misleading at the date of the Placing
and Open Offer Agreement or becoming untrue or inaccurate or misleading at any
time between such date and Admission of the Firm Placing Shares by reference
to the facts and circumstances from time to time subsisting;
4. the Company having complied with all of its
obligations under the Placing and Open Offer Agreement which fall to be
performed or satisfied on or prior to Admission of the Firm Placing Shares;
5. the execution and delivery of the Placing
Supplement; and
6. in the opinion of the Bookrunners (acting in
good faith), there having been no material adverse change in, or any
development involving a prospective material adverse change in, or affecting,
the condition (financial, operational, legal or otherwise) or the earnings,
management, business affairs, solvency, credit rating or prospects of the
Company, or of the Group taken as a whole, whether or not arising in the
ordinary course of business ("Material Adverse Change").
The Bookrunner may, at its discretion and upon such terms as it thinks fit,
waive compliance by the Company with the whole or any part of certain of the
Company's obligations in relation to the Firm Placing Conditions or extend the
time or date provided for fulfilment of certain such Conditions in respect of
all or any part of the performance thereof. The conditions in the Firm Placing
and Open Offer Agreement relating to (amongst other things) Admission of the
Firm Placing Shares taking place may not be waived. Any such extension or
waiver will not affect Placees' commitments as set out in this Announcement.
If: (i) any of the Firm Placing Conditions are not fulfilled or (where
permitted) waived by the Bookrunner by the relevant time or date specified
(or such later time or date as the Company and the Bookrunner may agree); or
(ii) the Placing and Open Offer Agreement is terminated in the circumstances
specified below under "Right to terminate under the Placing and Open Offer
Agreement- Firm Placing", the Placing will not proceed and the Placees' rights
and obligations hereunder in relation to the Placing Shares shall cease and
terminate at such time and each Placee agrees that no claim can be made by it
or on its behalf (or any person on whose behalf the Placee is acting) in
respect thereof.
None of the Bookrunner, nor the Company, nor any of their respective
affiliates, agents, directors, officers or employees shall have any liability
to any Placee (or to any other person whether acting on behalf of a Placee or
otherwise) in respect of any decision they may make as to whether or not to
waive or to extend the time and/or date for the satisfaction of any Firm
Placing Condition, nor for any decision they may make as to the satisfaction
of any Firm Placing Condition or in respect of the Firm Placing generally, and
by participating in the Firm Placing each Placee agrees that any such decision
is within the absolute discretion of the Bookrunner.
The Firm Placing is not conditional on completion of the Conditional Placing
and the Firm Placing may complete even if the conditions for the Conditional
Placing are not satisfied or waived or the obligations of the Bookrunner under
the Placing and Open Offer Agreement are terminated after completion of the
Firm Placing.
Conditions of the Conditional Placing
The Conditional Placing is conditional upon the Placing and Open Offer
Agreement becoming unconditional in respect of the Conditional Placing and not
having been terminated in accordance with its terms. The Bookrunner's
obligations in respect of the Conditional Placing under the Placing and Open
Offer Agreement are conditional on customary conditions (the "Conditional
Placing Conditions", and together with the Firm Placing Conditions, the
"Conditions" (as applicable)): including (amongst others):
1. certain announcement obligations;
2. Admission of the Conditional Placing Shares
occurring no later than 8.00 a.m. (London time) on 3 June 2024 (or such later
time and/or date, not being later than 8.00 a.m. (London time) on 17 June 2024
as the Bookrunner may otherwise agree with the Company);
3. the passing of the shareholder resolutions in
the approved terms to be set out in the notice convening the general meeting
of the Company;
4. none of the warranties contained in the Placing
and Open Offer Agreement, in the opinion of the Bookrunner (acting in good
faith), being untrue or inaccurate or misleading at the date of the Placing
and Open Offer Agreement or becoming untrue or inaccurate or misleading at any
time between such date and Admission of the Conditional Placing Shares by
reference to the facts and circumstances from time to time subsisting;
5. the Company having complied with all of its
obligations under the Placing and Open Offer Agreement and the intermediaries
agreements (including any applicable master intermediary agreements) relating
to the REX Retail Offer which fall to be performed or satisfied on or prior to
Admission of the Conditional Placing Shares;
6. the Placing, Open Offer and REX Retail Offer
raising gross proceeds of not less than £6.0 million;
7. the execution and delivery of the Placing
Supplement; and
8. in the opinion of the Bookrunner (acting in
good faith), there having been no Material Adverse Change.
The Bookrunner may, at its discretion and upon such terms as it thinks fit,
waive compliance by the Company with the whole or any part of certain of the
Company's obligations in relation to the Conditional Placing Conditions or
extend the time or date provided for fulfilment of certain such Conditions in
respect of all or any part of the performance thereof. The conditions in the
Conditional Placing and Open Offer Agreement relating to (amongst other
things) Admission of the Conditional Placing Shares taking place may not be
waived. Any such extension or waiver will not affect Placees' commitments as
set out in this Announcement.
If: (i) any of the Conditional Placing Conditions are not fulfilled or (where
permitted) waived by the Bookrunner by the relevant time or date specified
(or such later time or date as the Company and the Bookrunner may agree); or
(ii) the Placing and Open Offer Agreement is terminated in the circumstances
specified below under "Right to terminate under the Placing and Open Offer
Agreement - Conditional Placing" or "Right to terminate under the Placing and
Open Offer Agreement - Firm Placing", the Placing will not proceed and the
Placees' rights and obligations hereunder in relation to the Placing Shares
shall cease and terminate at such time and each Placee agrees that no claim
can be made by it or on its behalf (or any person on whose behalf the Placee
is acting) in respect thereof.
None of the Bookrunner, nor the Company, nor any of their respective
affiliates, agents, directors, officers or employees shall have any liability
to any Placee (or to any other person whether acting on behalf of a Placee or
otherwise) in respect of any decision they may make as to whether or not to
waive or to extend the time and/or date for the satisfaction of any
Conditional Placing Condition, nor for any decision they may make as to the
satisfaction of any Conditional Placing Condition or in respect of the
Conditional Placing generally, and by participating in the Conditional Placing
each Placee agrees that any such decision is within the absolute discretion of
the Bookrunner.
Right to terminate under the Placing and Open Offer Agreement - Firm Placing
The Bookrunner in its absolute discretion may terminate its obligations under
the Placing and Open Offer Agreement (in respect of both the Firm Placing and
the Conditional Placing) by notice to the Company, in each case if at any time
prior to Admission of the Firm Placing Shares, among other things:
1. there has been a breach by the Company of any
of its material obligations contained in the Placing and Open Offer Agreement;
2. it comes to the knowledge of the Bookrunner
that any of the warranties contained in the Placing and Open Offer Agreement
either was untrue, inaccurate or misleading when made and/or would be if such
warranties were deemed to be repeated at any time before Admission of the Firm
Placing Shares) by reference to the facts and circumstances then subsisting,
which is material in the context of the Placing;
3. if any of the Firm Placing Conditions have (i)
become incapable of satisfaction or (ii) not been satisfied before the latest
time provided in the Placing and Open Offer Agreement and have not been waived
if capable of being waived by the Bookrunner;
4. in the opinion of the Bookrunner (acting in
good faith), there has been a Material Adverse Change; or
the occurrence of certain force majeure events. Upon such termination, the
Bookrunner shall be released and discharged (except for any liability arising
before or in relation to such termination) from its obligations under or
pursuant to the Placing and Open Offer Agreement subject to certain
exceptions.
By participating in the Placing, each Placee agrees that (i) the exercise by
the Bookrunner of any right of termination or other discretion relating to the
Firm Placing under the Placing and Open Offer Agreement shall be within the
absolute discretion of the Bookrunner and that it need not make any reference
to, or consult with, Placees and that it shall have no liability to Placees
whatsoever in connection with any such exercise or failure to exercise and
(ii) its rights and obligations relating to the Firm Placing terminate only in
the circumstances described above under "Right to terminate under the Placing
and Open Offer Agreement - Firm Placing" and "Conditions of the Firm Placing",
and its participation will not be capable of rescission or termination by it
after oral confirmation by the Bookrunner of the allocation and commitments
following the close of the Bookbuild, including if the conditions for the
Conditional Placing are not satisfied or the Bookrunner exercises its right to
terminate its obligations under the Placing and Open Offer Agreement after
completion of the Firm Placing.
Right to terminate under the Placing Agreement - Conditional Placing
The Bookrunner in its absolute discretion may terminate its obligations under
the Placing and Open Offer Agreement by notice to the Company, if at any time
prior to Admission of the Conditional Placing Shares (including, for the
avoidance of doubt during the period after Admission of the Firm Placing
Shares), among other things:
1. where there has been a breach by the Company of
any of its material obligations contained in the Placing and Open Offer
Agreement;
2. it comes to the knowledge of the Bookrunner
that any of the warranties contained in the Placing and Open Offer Agreement
either was untrue, inaccurate or misleading when made and/or would be if such
warranties were deemed to be repeated at any time before Admission of the
Conditional Placing Shares by reference to the facts and circumstances then
subsisting, which is material in the context of the Placing;
3. if any of the Conditional Placing Conditions
have (i) become incapable of satisfaction or (ii) not been satisfied before
the latest time provided in the Placing and Open Offer Agreement and have not
been waived if capable of being waived by the Bookrunner;
4. in the opinion of the Bookrunner (acting in
good faith), there has been a Material Adverse Change; or
the occurrence of certain force majeure events. Upon such termination, the
Bookrunner shall be released and discharged (except for any liability arising
before or in relation to such termination) from its obligations under or
pursuant to the Placing and Open Offer Agreement subject to certain
exceptions.
By participating in the Placing, Placees agree that the exercise by the
Bookrunner of any right of termination or other discretion under the Placing
and Open Offer Agreement shall be within the absolute discretion of the
Bookrunner and that it need not make any reference to, or consult with,
Placees and that it shall have no liability to Placees whatsoever in
connection with any such exercise or failure to exercise.
By participating in the Placing, each Placee agrees that (i) the exercise by
the Bookrunner of any right of termination or other discretion relating to the
Conditional Placing under the Placing and Open Offer Agreement shall be within
the absolute discretion of the Bookrunner and that it need not make any
reference to, or consult with, Placees and that it shall have no liability to
Placees whatsoever in connection with any such exercise or failure to exercise
and (ii) its rights and obligations relating to the Conditional Placing
terminate only in the circumstances described above under "Right to terminate
under the Placing and Open Offer Agreement - Conditional Placing" and
"Conditions of the Conditional Placing", and its participation will not be
capable of rescission or termination by it after oral confirmation by the
Bookrunner of the allocation and commitments following the close of the
Bookbuild
Lock-up Arrangements
The Company has undertaken to the Bookrunner that, between the date of the
Placing and Open Offer Agreement and 12 months after each Admission, it will
not offer, issue, sell or otherwise dispose of (or announce an intention of
doing so) any shares of the Company, or any securities convertible into or
exchangeable for or carrying rights to acquire other shares of the Company,
whether settled in cash or otherwise, without prior consent from the
Bookrunner. However, this undertaking shall not prevent or restrict the grant
of options under, or the allotment and issue of shares pursuant to options
under, any existing employee share schemes of the Company (in accordance with
its normal practice) nor the allotment and issue of shares of the Company
following exercise of any warrants granted prior to the date of the Placing
and Open Offer Agreement to Riverfort Global Opportunities PCC Limited or
otherwise in connection with the equity pre-payment facility entered into by
the Company and the warrant instrument granted by the Company, each dated 31
March 2023 (provided, for the avoidance of doubt, that no further drawdown may
be made under such facility without the prior written consent of the
Bookrunner). By participating in the Placing, Placees agree that the exercise
by the Bookrunner of any power to grant consent to the undertaking by the
Company of a transaction which would otherwise be subject to the lock-up
provisions under the Placing and Open Offer Agreement shall be within the
absolute discretion of the Bookrunner and that it need not make any reference
to, or consult with, Placees and that it shall have no liability to Placees
whatsoever in connection with any such exercise of the power to grant consent.
Registration and Settlement
Settlement of transactions in the Placing Shares (ISIN: GB00B1VKB244)
following each Admission will take place within the system administered by
Euroclear UK & International Limited ("CREST"), subject to certain
exceptions. The Bookrunner reserves the right to require settlement for, and
delivery of, the Placing Shares (or any part thereof) to Placees by such other
means that they may deem necessary if delivery or settlement is not possible
or practicable within the CREST system or would not be consistent with the
regulatory requirements in the Placee's jurisdiction.
Following the close of the Bookbuild, each Placee to be allocated Placing
Shares in the Placing will be sent a contract note in accordance with the
standing arrangements in place with the Bookrunner stating the number of
Placing Shares allocated to them at the Issue Price, the number of Firm
Placing Shares and Conditional Placing Shares included in the allocation of
Placing Shares, the aggregate amount owed by such Placee to the Bookrunner in
respect of Firm Placing Shares and Conditional Placing Shares and settlement
instructions. Each Placee agrees that it will do all things necessary to
ensure that delivery and payment is completed in accordance with the standing
CREST or certificated settlement instructions in respect of the Firm Placing
Shares and the Conditional Placing Shares that it has in place with the
Bookrunner.
The Company will deliver the Placing Shares to a CREST account operated by the
Bookrunner as agent for the Company and the Bookrunner will enter its delivery
instruction into the CREST system. The input to CREST by a Placee of a
matching or acceptance instruction will then allow delivery of the relevant
Placing Shares to that Placee against payment.
It is expected that settlement in respect of (i) the Firm Placing Shares will
take place on 15 May 2024 and (ii) in respect of the Conditional Placing
Shares will be on 3 June 2024, in each case on a delivery versus payment
basis.
Interest is chargeable daily on payments not received from Placees on the due
date in accordance with the arrangements set out above at the rate of two
percentage points above SONIA as determined by the Bookrunner.
Each Placee is deemed to agree that, if it does not comply with these
obligations, the Bookrunner may sell any or all of the Placing Shares
allocated to that Placee on such Placee's behalf and retain from the proceeds,
for the Bookrunner's account and benefit, an amount equal to the aggregate
amount owed by the Placee plus any interest due. The relevant Placee will,
however, remain liable for any shortfall below the aggregate amount owed by it
and will be required to bear any stamp duty or stamp duty reserve tax or other
taxes or duties (together with any interest or penalties) imposed in any
jurisdiction which may arise upon the sale of such Placing Shares on such
Placee's behalf.
If Placing Shares are to be delivered to a custodian or settlement agent,
Placees should ensure that the contract note is copied and delivered
immediately to the relevant person within that organisation. Insofar as
Placing Shares are issued in a Placee's name or that of its nominee or in the
name of any person for whom a Placee is contracting as agent or that of a
nominee for such person, such Placing Shares should, subject as provided
below, be so registered free from any liability to UK stamp duty or stamp duty
reserve tax. If there are any circumstances in which any stamp duty or stamp
duty reserve tax or other similar taxes or duties (including any interest and
penalties relating thereto) is payable in respect of the allocation,
allotment, issue, sale, transfer or delivery of the Placing Shares (or, for
the avoidance of doubt, if any stamp duty or stamp duty reserve tax is payable
in connection with any subsequent transfer of or agreement to transfer Placing
Shares), neither the Bookrunner nor the Company shall be responsible for
payment thereof.
Representations, warranties, undertakings and acknowledgements
By participating in the Placing each Placee (and any person acting on such
Placee's behalf) irrevocably acknowledges, confirms, undertakes, represents,
warrants and agrees (as the case may be) with the Bookrunner (in its capacity
as bookrunner and placing agent of the Company in respect of the Placing) and
the Company, in each case as a fundamental term of their application for
Placing Shares, the following:
General
1. it has read and understood this Announcement in
its entirety and its subscription for Placing Shares (comprising Firm Placing
Shares and Conditional Placing Shares) is subject to and based upon all the
terms, conditions, representations, warranties, acknowledgements, agreements
and undertakings and other information contained herein and it has not relied
on, and will not rely on, any information given or any representations,
warranties or statements made at any time by any person in connection with the
Placing, the Company, the Placing Shares or otherwise other than the
information contained in the Placing Documents and the Publicly Available
Information;
2. the Ordinary Shares are admitted to trading on
AIM and that the Company is therefore required to publish certain business and
financial information in accordance with the rules and practices of AIM,
which includes a description of the Company's business and the Company's
financial information, including balance sheets and income statements, and
that it is able to obtain or has access to such information without undue
difficulty, and is able to obtain access to such information or comparable
information concerning any other publicly traded companies, without undue
difficulty;
3. the person whom it specifies for registration
as holder of the Placing Shares will be (a) itself or (b) its nominee, as the
case may be. Neither the Bookrunner nor the Company will be responsible for
any liability to stamp duty or stamp duty reserve tax or other similar taxes
or duties imposed in any jurisdiction (including interest and penalties
relating thereto) ("Indemnified Taxes"). Each Placee and any person acting on
behalf of such Placee agrees to indemnify the Company and the Bookrunner on an
after-tax basis in respect of any Indemnified Taxes;
4. neither the Bookrunner nor any of its
affiliates, agents, directors, officers and employees accepts any
responsibility for any acts or omissions of the Company or any of the
directors of the Company or any other person (other than the Bookrunner) in
connection with the Placing;
5. time is of the essence as regards its
obligations under this Announcement;
6. any document that is to be sent to it in
connection with the Placing will be sent at its risk and may be sent to it at
any address provided by it to the Bookrunner;
No distribution of Announcement
7. it will not redistribute, forward, transfer,
duplicate or otherwise transmit this Announcement or any part of it, or any
other presentational or other material concerning the Placing (including
electronic copies thereof) to any person and it represents that it has not
redistributed, forwarded, transferred, duplicated, or otherwise transmitted
any such materials to any person;
No prospectus
8. no prospectus or other offering document is
required under the EU Prospectus Regulation or the UK Prospectus Regulation,
nor will one be prepared in connection with the Bookbuild, the Placing or the
Placing Shares and it has not received and will not receive a prospectus or
other offering document in connection with the Bookbuild, the Placing or the
Placing Shares;
Purchases by the Bookrunner for its own account
9. in connection with the Placing, the Bookrunner
and any of its affiliates acting as an investor for its own account may
subscribe for Placing Shares in the Company and in that capacity may retain,
purchase or sell for its own account such Placing Shares in the Company and
any securities of the Company or related investments and may offer or sell
such securities or other investments otherwise than in connection with the
Placing. Accordingly, references in this Announcement to the Placing Shares
being issued, offered or placed should be read as including any issue,
offering or placement of such shares in the Company to the Bookrunner or any
of its affiliates acting in such capacity;
10. the Bookrunner and its affiliates may enter into
financing arrangements and swaps with investors in connection with which the
Bookrunner and any of their affiliates may from time to time acquire, hold or
dispose of such securities of the Company, including the Placing Shares;
11. the Bookrunner does not intend to disclose the
extent of any investment or transactions referred to in paragraphs 9 and 10
above otherwise than in accordance with any legal or regulatory obligation to
do so;
No fiduciary duty or client of the Bookrunner
12. the Bookrunner does not owe any fiduciary or
other duties to any Placee in respect of any representations, warranties,
undertakings or indemnities in the Placing and Open Offer Agreement;
13. its participation in the Placing is on the basis
that it is not and will not be a client of the Bookrunner in connection with
its participation in the Placing and that the Bookrunner has no duties or
responsibilities to it for providing the protections afforded to its clients
or customers or for providing advice in relation to the Placing nor in respect
of any representations, warranties, undertakings or indemnities contained in
the Placing and Open Offer Agreement nor for the exercise or performance of
any of its rights and obligations thereunder including any rights to waive or
vary any conditions or exercise any termination right;
No responsibility of the Bookrunner for information
14. the content of the Placing Documents and the
Publicly Available Information has been prepared by and is exclusively the
responsibility of the Company and neither the Bookrunner nor its respective
affiliates agents, directors, officers or employees nor any person acting on
behalf of any of them is responsible for or has or shall have any
responsibility or liability for any information, representation or statement
contained in, or omission from, the Placing Documents, the Publicly Available
Information or otherwise nor will they be liable for any Placee's decision to
participate in the Placing based on any information, representation, warranty
or statement contained in the Placing Documents, the Publicly Available
Information or otherwise, provided that nothing in this paragraph excludes the
liability of any person for fraudulent misrepresentation made by such person;
Reliance on information regarding the Placing
15.
(a) the only information on which it is entitled
to rely and on which such Placee has relied in committing itself to subscribe
for Placing Shares is contained in the Placing Documents, or any Publicly
Available Information (save that in the case of Publicly Available
Information, a Placee's right to rely on that information is limited to the
right that such Placee would have as a matter of law in the absence of this
paragraph 15(a)), such information being all that such Placee deems necessary
or appropriate and sufficient to make an investment decision in respect of the
Placing Shares;
(b) it has neither received nor relied on any
other information given, or representations, warranties or statements, express
or implied, made, by the Bookrunner or the Company nor any of their respective
affiliates, agents, directors, officers or employees acting on behalf of any
of them (including in any management presentation delivered in respect of the
Bookbuild) with respect to the Company, the Placing or the Placing Shares or
the accuracy, completeness or adequacy of any information contained in the
Placing Documents, or the Publicly Available Information or otherwise;
(c) neither the Bookrunner, nor the Company, nor
any of their respective affiliates, agents, directors, officers or employees
or any person acting on behalf of any of them has provided, nor will provide,
it with any material or information regarding the Placing Shares or the
Company or any other person other than the information in the Placing
Documents or the Publicly Available Information; nor has it requested of any
of the Bookrunner, the Company or any of their respective affiliates or any
person acting on behalf of any of them to provide it with any such material or
information; and
(d) neither the Bookrunner nor the Company will be
liable for any Placee's decision to participate in the Placing based on any
other information, representation, warranty or statement,
provided that nothing in this paragraph excludes the liability of any person
for fraudulent misrepresentation made by that person;
Conducted own investigation and due diligence
16. it may not rely, and has not relied, on any
investigation that the Bookrunner, any of its affiliates or any person acting
on its behalf, may have conducted with respect to the Placing Shares, the
terms of the Placing or the Company, and none of such persons has made any
representation, express or implied, with respect to the Company, the Placing,
the Placing Shares or the accuracy, completeness or adequacy of the
information in the Placing Documents, the Publicly Available Information or
any other information;
17. in making any decision to subscribe for Placing
Shares it:
(a) has such knowledge and experience in
financial and business matters to be capable of evaluating the merits and
risks of subscribing for the Placing Shares;
(b) will not look to the Bookrunner for all or
part of any such loss it may suffer;
(c) is experienced in investing in securities of
this nature in this sector and is aware that it may be required to bear, and
is able to bear, the economic risk of an investment in the Placing Shares;
(d) is able to sustain a complete loss of an
investment in the Placing Shares;
(e) has no need for liquidity with respect to its
investment in the Placing Shares;
(f) has made its own assessment and has
satisfied itself concerning the relevant tax, legal, currency and other
economic considerations relevant to its investment in the Placing Shares; and
(g) has conducted its own due diligence,
examination, investigation and assessment of the Company, the Placing Shares
and the terms of the Placing and has satisfied itself that the information
resulting from such investigation is still current and relied on that
investigation for the purposes of its decision to participate in the Placing;
Capacity and authority
18. it is subscribing for the Placing Shares for its
own account or for an account with respect to which it exercises sole
investment discretion and has the authority to make and does make the
acknowledgements, representations and agreements contained in this
Announcement;
19. it is acting as principal only in respect of the
Placing or, if it is acting for any other person, it is:
(a) duly authorised to do so and has full power to
make the acknowledgments, representations and agreements herein on behalf of
each such person; and
(b) will remain liable to the Company and/or the
Bookrunner for the performance of all its obligations as a Placee in respect
of the Placing (regardless of the fact that it is acting for another person);
20. it and any person acting on its behalf is entitled
to subscribe for the Placing Shares under the laws and regulations of all
relevant jurisdictions that apply to it and that it has fully observed such
laws and regulations, has capacity and authority and is entitled to enter into
and perform its obligations as a subscriber of Placing Shares and will honour
such obligations, and has obtained all such governmental and other guarantees,
permits, authorisations, approvals and consents which may be required
thereunder and complied with all necessary formalities to enable it to commit
to this participation in the Placing and to perform its obligations in
relation thereto (including, without limitation, in the case of any person on
whose behalf it is acting, all necessary consents and authorities to agree to
the terms set out or referred to in this Announcement) and will honour such
obligations and that it has not taken any action or omitted to take any action
which will or may result in the Bookrunner, the Company or any of their
respective directors, officers, agents, employees or advisers acting in breach
of the legal or regulatory requirements of any jurisdiction in connection with
the Placing;
21. where it is subscribing for Placing Shares for one
or more managed accounts, it is authorised in writing by each managed account
to subscribe for the Placing Shares for each managed account;
22. it irrevocably appoints any duly authorised
officer of the Bookrunner as its agent for the purpose of executing and
delivering to the Company and/or its registrars any documents on its behalf
necessary to enable it to be registered as the holder of any of the Placing
Shares for which it agrees to subscribe for upon the terms of this
Announcement;
Excluded territories
23. the Placing Shares have not been and will not be
registered or otherwise qualified and that a prospectus will not be cleared
in respect of any of the Placing Shares under the securities laws or
legislation of the United States, Australia, New Zealand, Canada, Japan or the
Republic of South Africa, or any state, province, territory or jurisdiction
thereof;
24. the Placing Shares may not be offered, sold, or
delivered or transferred, directly or indirectly, in or into the jurisdictions
listed in paragraph 23 above or any jurisdiction (subject to certain
exceptions) in which it would be unlawful to do so and no action has been or
will be taken by any of the Company, the Bookrunner or any person acting on
behalf of the Company or the Bookrunner that would, or is intended to, permit
a public offer of the Placing Shares in the United States, Australia, New
Zealand, Canada, Japan or the Republic of South Africa or any country or
jurisdiction, or any state, province, territory or jurisdiction thereof, where
any such action for that purpose is required;
25. unless otherwise specifically agreed with the
Bookrunner, it is not and at the time the Placing Shares are subscribed for,
neither it nor the beneficial owner of the Placing Shares will be, a resident
of, nor have an address in, Australia, New Zealand, Japan, the Republic of
South Africa or any province or territory of Canada;
26. it may be asked to disclose in writing or orally
to the Bookrunner:
(a) if he or she is an individual, his or her
nationality; or
(b) if he or she is a discretionary fund manager,
the jurisdiction in which the funds are managed or owned;
Compliance with US securities laws
27. it, and any prospective beneficial owner for
whose account or benefit it is purchasing the Placing Shares, (i) is located
outside the United States and is acquiring the Placing Shares in an "offshore
transaction" as defined in, and in accordance with, Regulation S; and (ii)
has not been offered to purchase or subscribe for Placing Shares by means of
any "directed selling efforts" as defined in Regulation S;
28. it understands that the Placing Shares have not
been, and will not be, registered under the US Securities Act and may not be
offered, sold or resold in or into or from the United States except pursuant
to an effective registration under the US Securities Act, or pursuant to an
exemption from the registration requirements of the US Securities Act and in
accordance with applicable state securities laws;
29. it will not distribute, forward, transfer or
otherwise transmit this Announcement or any part of it, or any other
presentational or other materials concerning the Placing in or into or from
the United States (including electronic copies thereof) to any person, and it
has not distributed, forwarded, transferred or otherwise transmitted any such
materials to any person;
Compliance with selling restrictions and the EU Prospectus Regulation and UK
Prospectus Regulation
30. if in the United Kingdom, it is a Relevant Person
and it is a Qualified Investor (as such term is defined in Article 2(e) of the
UK Prospectus Regulation);
31. if in a Relevant Member State, unless otherwise
specifically agreed with the Bookrunner in writing, it is a Qualified
Investor (as such term is defined in Article 2(e) of the EU Prospectus
Regulation);
32. it has not offered or sold and will not offer or
sell any Placing Shares to persons in the United Kingdom except to Qualified
Investors (as such term is defined in Article 2(e) of the UK Prospectus
Regulation) or otherwise in circumstances which have not resulted in, and
which will not result in an offer to the public in the United Kingdom within
the meaning of the UK Prospectus Regulation;
33. it has not offered or sold and will not offer or
sell any Placing Shares to persons in a Relevant Member State except to
Qualified Investors or otherwise in circumstances which have not resulted in,
and which will not result in an offer to the public in any Relevant Member
State within the meaning of the EU Prospectus Regulation;
34. if a financial intermediary, as that term is used
in Article 5(1) of the UK Prospectus Regulation, the Placing Shares subscribed
for by it in the Placing will not be acquired on a non-discretionary basis on
behalf of, nor will they be acquired with a view to their offer or resale to,
persons in the United Kingdom other than Qualified Investors;
35. if a financial intermediary, as that term is used
in Article 5(1) of the EU Prospectus Regulation, the Placing Shares subscribed
for by it in the Placing will not be acquired on a non-discretionary basis on
behalf of, nor will they be acquired with a view to their offer or resale to,
persons in a Relevant Member State which has implemented the EU Prospectus
Regulation other than Qualified Investors, or in circumstances in which the
prior consent of the Bookrunner has been given to each proposed offer or
resale;
Compliance with FSMA, the UK financial promotion regime, and UK MAR
36. if in the United Kingdom, that it is a person (i)
having professional experience in matters relating to investments who falls
within the definition of "investment professionals" in Article 19(5) of the
Order or (ii) who falls within Article 49(2) (a) to (d) ("High Net Worth
Companies, Unincorporated Associations, etc") of the Order, or (iii) to whom
it may otherwise lawfully be communicated;
37. it has not offered or sold and will not offer or
sell any Placing Shares to persons in the United Kingdom, except to persons
whose ordinary activities involve them in acquiring, holding, managing or
disposing of investments (as principal or agent) for the purposes of their
business or otherwise in circumstances which have not resulted and which will
not result in an offer to the public in the United Kingdom within the meaning
of section 85(1) of the Financial Services and Markets Act 2000, as amended
("FSMA");
38. it has only communicated or caused to be
communicated and will only communicate or cause to be communicated any
invitation or inducement to engage in investment activity (within the meaning
of section 21 of FSMA) relating to the Placing Shares in circumstances in
which section 21(1) of FSMA does not require approval of the communication by
an authorised person and it acknowledges and agrees that the Placing Documents
have not and will not have been approved by the Bookrunner in its capacity as
an authorised person under section 21 of the FSMA and it may not therefore be
subject to the controls which would apply if it was made or approved as a
financial promotion by an authorised person;
39. it has complied and will comply with all
applicable laws with respect to anything done by it or on its behalf in
relation to the Placing Shares (including all applicable provisions in FSMA
and the UK version of Regulation (EU) No. 596/2014 of the European Parliament
and of the Council of 16 April 2014 on market abuse, as retained as part of UK
law by virtue of the EUWA ("UK MAR")) in respect of anything done in, from or
otherwise involving, the United Kingdom);
Compliance with laws
40. if it is a pension fund or investment company, its
subscription for Placing Shares is in full compliance with applicable laws and
regulations;
41. it has complied with its obligations under the
Criminal Justice Act 1993 and Articles 8, 10 and 12 of UK MAR and in
connection with money laundering and terrorist financing under the Proceeds
of Crime Act 2002 (as amended), the Terrorism Act 2000, the Terrorism Act 2006
and the Money Laundering, Terrorist Financing and Transfer of Funds
(Information on the Payer) Regulations 2017 and any related or similar rules,
regulations or guidelines, issued, administered or enforced by any government
agency having jurisdiction in respect thereof (the "Regulations") and the
Money Laundering Sourcebook of the FCA and, if making payment on behalf of a
third party, that satisfactory evidence has been obtained and recorded by it
to verify the identity of the third party as required by the Regulations;
42. in order to ensure compliance with the
Regulations, the Bookrunner (for itself and as agent on behalf of the Company)
or the Company's registrars may, in their absolute discretion, require
verification of its identity. Pending the provision to the Bookrunner or the
Company's registrars, as applicable, of evidence of identity, definitive
certificates in respect of the Placing Shares may be retained at the
Bookrunner's absolute discretion or, where appropriate, delivery of the
Placing Shares to it in uncertificated form may be delayed at the
Bookrunner's or the Company's registrars', as the case may be, absolute
discretion. If within a reasonable time after a request for verification of
identify the Bookrunner (for itself and as agent on behalf of the Company) or
the Company's registrars have not received evidence satisfactory to them,
either the Bookrunner and/or the Company may, at its absolute discretion,
terminate its commitment in respect of the Placing, in which event the monies
payable on acceptance of allotment will, if already paid, be returned without
interest to the account of the drawee's bank from which they were originally
debited;
Depositary receipts and clearance services
43. the allocation, allotment, issue and delivery to
it, or the person specified by it for registration as holder, of Placing
Shares will not give rise to a stamp duty or stamp duty reserve tax liability
under (or at a rate determined under) any of sections 67, 70, 93 or 96 of the
Finance Act 1986 (depositary receipts and clearance services) and that the
Placing Shares are not being acquired in connection with arrangements to issue
depositary receipts or to issue or transfer Placing Shares into a clearance
service;
Undertaking to make payment
44. it (and any person acting on its behalf) has the
funds available to pay for the Placing Shares for which it has agreed to
subscribe and acknowledges and agrees that it will make payment in respect of
the Placing Shares allocated to it in accordance with this Announcement on the
due time and date set out herein, failing which the relevant Placing Shares
may be placed with other subscribers or sold as the Bookrunner may in its sole
discretion determine and without liability to such Placee, who will remain
liable for any amount by which the net proceeds of such sale falls short of
the product of the relevant Issue Price and the number of Placing Shares
allocated to it and will be required to bear any stamp duty, stamp duty
reserve tax or other taxes or duties (together with any interest, fines or
penalties) imposed in any jurisdiction which may arise upon the sale of such
Placee's Placing Shares;
Money held on account
45. any money held in an account with the Bookrunner
on behalf of the Placee and/or any person acting on behalf of the Placee will
not be treated as client money within the meaning of the relevant rules and
regulations of the FCA made under the FSMA. Each Placee acknowledges that the
money will not be subject to the protections conferred by the client money
rules: as a consequence this money will not be segregated from the
Bookrunner's money in accordance with the client money rules and will be held
by it under a banking relationship and not as trustee;
Allocation
46. its allocation (if any) of Placing Shares will
represent a maximum number of Placing Shares which it will be entitled, and
required, to subscribe for, and that the Bookrunner or the Company may call
upon it to subscribe for a lower number of Placing Shares (if any), but in no
event in aggregate more than the aforementioned maximum;
No recommendation
47. neither the Bookrunner, nor any of its affiliates,
nor any person acting on behalf of them, is making any recommendations to it,
advising it regarding the suitability of any transactions it may enter into in
connection with the Placing;
Inside information
48. if it has received any 'inside information' (for
the purposes of UK MAR and section 56 of the Criminal Justice Act 1993) in
relation to the Company and its securities in advance of the Placing, it
confirms that it has received such information within the market soundings
regime provided for in article 11 of UK MAR and associated delegated
regulations and it has not:
(a) used that inside information to acquire or
dispose of securities of the Company or financial instruments related thereto
or cancel or amend an order concerning the Company's securities or any such
financial instruments;
(b) used that inside information to encourage,
require, recommend or induce another person to deal in the securities of the
Company or financial instruments related thereto or to cancel or amend an
order concerning the Company's securities or such financial instruments; or
(c) disclosed such information to any person,
prior to the information being made publicly available;
Rights and remedies
49. the rights and remedies of the Company and the
Bookrunner under the terms and conditions in this Announcement are in addition
to any rights and remedies which would otherwise be available to each of them
and the exercise or partial exercise of one will not prevent the exercise of
others; and
Governing law and jurisdiction
50. these terms and conditions of the Placing and any
agreements entered into by it pursuant to the terms and conditions of the
Placing, and all non-contractual or other obligations arising out of or in
connection with them, shall be governed by and construed in accordance with
the laws of England and it submits (on behalf of itself and on behalf of any
person on whose behalf it is acting) to the exclusive jurisdiction of the
English courts as regards any claim, dispute or matter arising out of any such
contract (including any dispute regarding the existence, validity or
termination of such contract or relating to any non-contractual or other
obligation arising out of or in connection with such contract), except that
enforcement proceedings in respect of the obligation to make payment for the
Placing Shares (together with any interest chargeable thereon) may be taken by
either the Company or the Bookrunner in any jurisdiction in which the relevant
Placee is incorporated or in which any of its securities have a quotation on a
recognised stock exchange.
The foregoing representations, warranties, confirmations, acknowledgements,
agreements and undertakings are given for the benefit of the Company as well
as the Bookrunner and are irrevocable. The Bookrunner, the Company and their
respective affiliates and others will rely upon the truth and accuracy of the
foregoing representations, warranties, confirmations, acknowledgements,
agreements and undertakings. Each prospective Placee, and any person acting on
behalf of such Placee, irrevocably authorises the Company and the Bookrunner
to produce this Announcement, pursuant to, in connection with, or as may be
required by any applicable law or regulation, administrative or legal
proceeding or official inquiry with respect to the matters set forth herein.
Indemnity
By participating in the Placing, each Placee (and any person acting on such
Placee's behalf) agrees to indemnify on an after tax basis and hold the
Company, the Bookrunner and their respective affiliates, agents, directors,
officers and employees harmless from any and all costs, claims, liabilities
and expenses (including legal fees and expenses) arising out of or in
connection with any breach of the representations, warranties,
acknowledgements, agreements and undertakings given by the Placee (and any
person acting on such Placee's behalf) in this Announcement or incurred by the
Bookrunner, the Company or each of their respective affiliates, agents,
directors, officers or employees arising from the performance of the Placees'
obligations as set out in this Announcement, and further agrees that the
provisions of this Announcement shall survive after completion of the Placing.
Taxation
The agreement to allot and issue Placing Shares to Placees (and/or to persons
for whom such Placee is contracting as agent) free of stamp duty and stamp
duty reserve tax relates only to their allotment and issue to Placees, or such
persons as they nominate as their agents, direct from the Company for the
Placing Shares in question. Such agreement also assumes that the Placing
Shares are not being acquired in connection with arrangements to issue
depositary receipts or to issue or transfer the Placing Shares into a
clearance service. If there are any such arrangements, or the settlement
relates to any other dealing in the Placing Shares, stamp duty or stamp duty
reserve tax or other similar taxes or duties may be payable, for which neither
the Company nor the Bookrunner will be responsible and the Placees shall
indemnify the Company and the Bookrunner on an after-tax basis for any stamp
duty or stamp duty reserve tax or other similar taxes or duties (together with
interest, fines and penalties) in any jurisdiction paid by the Company or the
Bookrunner in respect of any such arrangements or dealings. If this is the
case, each Placee should seek its own advice and notify the Bookrunner
accordingly. Placees are advised to consult with their own advisers regarding
the tax aspects of the subscription for Placing Shares.
The Company and the Bookrunner are not liable to bear any taxes that arise on
a sale of Placing Shares subsequent to their acquisition by Placees, including
any taxes arising otherwise than under the laws of the United Kingdom. Each
prospective Placee should, therefore, take its own advice as to whether any
such tax liability arises and notify the Bookrunner and the Company
accordingly. Furthermore, each prospective Placee agrees to indemnify on an
after-tax basis and hold the Bookrunner and/or the Company and their
respective affiliates harmless from any and all interest, fines or penalties
in relation to stamp duty, stamp duty reserve tax and all other similar duties
or taxes in any jurisdiction to the extent that such interest, fines or
penalties arise from the unreasonable default or delay of that Placee or its
agent.
In addition, Placees should note that they will be liable for any stamp duty
and all other stamp, issue, securities, transfer, registration, documentary or
other duties or taxes (including any interest, fines or penalties relating
thereto) payable, whether inside or outside the UK, by them or any other
person on the subscription, acquisition, transfer or sale by them of any
Placing Shares or the agreement by them to subscribe for, acquire, transfer or
sell any Placing Shares.
No statement in the Placing Documents is intended to be a profit forecast or
estimate, and no statement in the Placing Documents should be interpreted to
mean that earnings per share of the Company for the current or future
financial years would necessarily match or exceed the historical published
earnings per share of the Company. Past performance is no guide to future
performance and persons needing advice should consult an independent financial
adviser.
The price of shares and any income expected from them may go down as well as
up and investors may not get back the full amount invested upon disposal of
the shares. Past performance is no guide to future performance, and persons
needing advice should consult an independent financial adviser.
The Placing Shares to be issued pursuant to the Placing will not be admitted
to trading on any stock exchange other than AIM, a market operated by the
London Stock Exchange.
Neither the content of the Company's website nor any website accessible by
hyperlinks on the Company's website is incorporated in, or forms part of, this
Announcement or any other Placing Document.
APPENDIX III - DEFINITIONS
The following definitions apply throughout this Announcement unless the
context otherwise requires:
"Admission" means First Admission and/or Second Admission (as the context requires);
"AIM" AIM, the market of that name operated by London Stock Exchange
"AIM Rules" the AIM Rules for Companies and/or the AIM Rules for Nominated Advisers (as
the context may require)
"AIM Rules for Companies" the rules of AIM as set out in the publication entitled "AIM Rules for
Companies" published by the London Stock Exchange from time to time
"AIM Rules for Nominated Advisers" the rules of AIM as set out in the publication entitled "AIM Rules for
Nominated Advisers" published by the London Stock Exchange from time to time
means this announcement including its Appendices
"Announcement"
"Basic Entitlements" or "Open Offer Entitlements" the Open Offer Shares which a Qualifying Shareholder is entitled to subscribe
for under the Open Offer calculated on the basis of 1 Open Offer Share for
every 1 Existing Ordinary Share held by that Qualifying Shareholder as at the
Record Date as described in Part II of the Circular
"Bookbuild" the accelerated bookbuilding process which will be launched immediately
following this Announcement
Peel Hunt
"Bookrunner"
CE marking indicating that an in-vitro diagnostic device complies with
"CE-IVD" European Directive (IVDD 98/79/EC)
"certificated" or "in certificated form" an Ordinary Share or other security recorded on a company's share register as
being held in certificated form (that is not in CREST)
"Circular" the circular to be posted to Shareholders shortly in relation to the
Fundraising and incorporating the Notice of General Meeting
"Company" or " genedrive" genedrive plc, a public limited company incorporated in England and Wales
under registered number 06108621
means the conditional placing of the Conditional Placing Shares pursuant to
"Conditional Placing" the Placing in accordance with Appendix II to this Announcement
means the New Ordinary Shares to be issued pursuant to the Conditional
Placing, the maximum number as specified in the executed Placing Terms
"Conditional Placing Shares"
has the meaning given to it in Appendix II of this Announcement
"Conditions"
"CREST" the relevant system (as defined in the Regulations) which enables title to
units of relevant securities (as defined in the Regulations) to be evidenced
and transferred without a written instrument and in respect of which Euroclear
is the Operator (as defined in the CREST Regulations)
"CREST Regulations" the Uncertificated Securities Regulations 2001 (SI 2001/3755) as amended
The Development and Validation of Technology for Time Critical Genomic Testing
"DEVOTE"
"Directors" the current directors of the Company
"EU" the European Union
"Euroclear" Euroclear UK & International Limited, the operator (as defined in the
CREST Regulations) of CREST
"Excess Application Facility" the arrangement pursuant to which a Qualifying Shareholder, who has taken up
his Basic Entitlement in full, can apply for additional Open Offer Shares in
accordance with the terms and conditions of the Open Offer as set out in the
Circular
"Existing Ordinary Shares" the Ordinary Shares in issue immediately prior to the Fundraising, all of
which are admitted to trading on AIM
"FCA" the Financial Conduct Authority of the United Kingdom
"FDA" the US Food and Drug Administration
"Firm Placing" means the firm placing of the Firm Placing Shares pursuant to the Placing in
accordance with Appendix II
means the New Ordinary Shares to be issued pursuant to the Firm Placing, the
"Firm Placing Share" maximum number as specified in the executed Placing Terms
means admission of the Firm Placing Shares to trading on AIM becoming
effective in accordance with Rule 6 of the AIM Rules
"First Admission"
"Form of Proxy" the form of proxy for use by Shareholders in relation to the General Meeting,
either online or a hard copy requested from Neville Registrars
"FSMA" the Financial Services and Markets Act 2000, as amended
"Fundraising" together, the Placing , the REX Offer and the Open Offer
"General Meeting" the general meeting of the Shareholders to be convened by the Notice of
General Meeting and set out in the Circular
"Group" the Company, its subsidiaries and subsidiary undertakings
"Intermediaries" means any intermediary financial institution that is appointed by the Company
in connection with the REX Offer pursuant to an Intermediaries Agreement and
"Intermediary" shall mean any one of them
"Intermediaries Agreements" means (a) the Master Intermediary Agreements and (b) the agreement(s) (if any)
between an Intermediary, the Company and Peel Hunt relating to the REX Offer,
setting out the terms and conditions of the REX Offer, and (c) the form of
subscription by the relevant Intermediary under the REX Offer
"ISIN" the International Securities Identification Number
"Issue Price" 1.5 pence per New Ordinary Share
"London Stock Exchange" London Stock Exchange plc
"MFT" Manchester University NHS Foundation Trust
"Minimum Proceeds" £6.0 million of gross proceeds required to be raised pursuant to the
Fundraising in order for the Conditional Placing, the REX Offer and the Open
Offer to be become unconditional
"New Ordinary Shares" the new Ordinary Shares to be issued pursuant to the Placing, the REX Offer
and the Open Offer
"NICE" UK's National Institute for Health and Care Excellence
"NICE DAP" The Diagnostics Assessment Programme which is part of NICE's activities on
evaluating medical technologies
The Early Value Assessment being an evidence-based approach designed to
"NICE EVA" or "EVA" improve the care of people and effective use of NHS resources through quicker
access to promising health technologies that address national unmet need
Neonatal intensive care unit
"NICU"
National Institute of Health and Care Research
"NIHR"
"Notice of General Meeting" the notice of the General Meeting which will be set out in the Circular
"OLS" Office for Life Sciences, part of the Department of Health and Social Care
the conditional invitation by the Company to Qualifying Shareholders to apply
to subscribe for Open Offer Shares at the Issue Price on the terms and subject
"Open Offer" to the conditions to be set out or referred to in the Circular
an entitlement to subscribe for Open Offer Shares, allocated to a Qualifying
Shareholder under the Open Offer (and, for the avoidance of doubt, references
to Open Offer Entitlements include Basic Entitlements and Excess Open Offer
Entitlements)
"Open Offer Entitlements"
"Open Offer Shares" up to 143,141,481 New Ordinary Shares to be offered to Qualifying Shareholders
pursuant to the Open Offer whose allotment and issue is conditional (amongst
other things) on the passing of the Resolutions
"Ordinary Shares" ordinary shares of 1.5 pence each in the capital of the Company
"Overseas Shareholders" Shareholders with registered addresses outside the UK or who are citizens of,
incorporated in, registered in or otherwise resident in, countries outside the
UK
"Peel Hunt" Peel Hunt LLP, the Company's nominated adviser, bookrunner and broker in
connection with the Placing and Open Offer
"Placee" eligible institutional investors procured by the Bookrunner and subscribing
for Placing Shares in the Placing
"Placing" the Firm Placing and/or the Conditional Placing (as the context requires)
"Placing and Open Offer Agreement" the placing and open offer agreement dated 9 May 2024 made between the Company
and the Bookrunner in relation to the Placing and Open Offer
"Placing Shares" means the Firm Placing Shares and the Conditional Placing Shares
"Placing Terms" has the meaning given to it in Appendix II to this Announcement
"Qualifying Shareholders" Shareholders at the Record Date other than Overseas Shareholders
"Record Date" 6.00 p.m. on 13 May 2024
"Relevant Persons" has the meaning set out in Appendix II of this Announcement
"Resolutions" the resolutions to be proposed at the General Meeting as set out in the Notice
of General Meeting
"Restricted Jurisdictions" each and any of the United States, Australia, Canada, Japan and the Republic
of South Africa
"REX Offer" means the conditional offer of the REX Offer Shares to be made to retail
investors by the Company through intermediaries using the REX platform and on
the basis of the terms and conditions to be set out in the REX Offer
Announcement and Intermediaries Agreements
"REX Offer Announcement" means the announcement to be released alongside this Announcement giving
details, among other things, of the REX Offer
"REX Offer Documents" means the announcement to be released alongside this Announcement giving
details, among other things, of the REX Offer
"REX Offer Shares" means the new Ordinary Shares to be made available under the REX Offer
means admission of the Conditional Placing Shares and such number of the REX
Offer Shares and Open Offer Shares as are subscribed for to trading on AIM
"Second Admission" becoming effective in accordance with Rule 6 of the AIM Rules
means the Conditional Placing Shares, the REX Offer Shares and the Open Offer
Shares
"Second Admission Shares"
"Shareholders" the holders of Ordinary Shares for the time being (each individually a
"Shareholder")
"United Kingdom" or "UK" the United Kingdom of Great Britain and Northern Ireland
"UK MAR" Regulation (EU) No. 596/2014 of the European Parliament and of the Council of
16 April 2014 on market abuse, as it forms part of UK domestic law by virtue
of the European Union (Withdrawal) Act 2018, as amended
"uncertificated" or "in uncertificated form" recorded on the register of members of the Company as being held in
uncertificated form in CREST and title to which, by virtue of the CREST
Regulations, may be transferred by means of CREST
"United States" or "US" the United States of America, its territories and possessions, any state of
the United States and the District of Columbia
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