TIDMDNL
RNS Number : 0970W
Diurnal Group PLC
21 April 2021
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INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OF
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NEITHER THIS ANNOUNCEMENT NOR ANYTHING CONTAINED HEREIN SHALL FORM
THE BASIS OF, OR BE RELIED UPON IN CONNECTION WITH, ANY OFFER OR
COMMITMENT WHATSOEVER IN ANY JURISDICTION.
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF REGULATION 2014/596/EU AS IT FORMS PART OF THE LAW
OF ENGLAND AND WALES BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL)
ACT 2018. IN ADDITION, MARKET SOUNDINGS WERE TAKEN IN RESPECT OF
THE MATTERS CONTAINED IN THIS ANNOUNCEMENT, WITH THE RESULT THAT
CERTAIN PERSONS BECAME AWARE OF SUCH INSIDE INFORMATION. UPON THE
PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION IS NOW
CONSIDERED TO BE IN THE PUBLIC DOMAIN AND SUCH PERSONS SHALL
THEREFORE CEASE TO BE IN POSSESSION OF INSIDE INFORMATION.
21 April 2021
Diurnal Group plc
("Diurnal" the "Company" or the "Group")
Proposed Placing, Subscription and Open Offer
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, today announces a proposed conditional Placing of Placing
Shares with institutional investors and a Subscription of
Subscription Shares by certain Directors to raise up to
approximately GBP 20.0 million in aggregate before expenses at the
Issue Price of 70 pence per New Ordinary Share and an Open Offer to
raise up to a further GBP2.0 million. Funds raised will be used
primarily to progress the Group's pivotal Phase 3 studies of
Efmody(R) (development name Chronocort(R)) as a treatment for
congenital adrenal hyperplasia (CAH) in the US through to
registration.
Highlights
-- The Placing to raise up to approximately GBP 20.0 million
will be conducted by way of an accelerated bookbuilding process
(the "Bookbuild"), which will be launched immediately following
this Announcement in accordance with the terms and conditions set
out in Appendix II.
-- Subject to successful closing of the Bookbuild, the Company
is also making an Open Offer, for up to 2,852,317 Open Offer
Shares, to raise up to approximately GBP2.0 million at the Issue
Price, on the basis of 2 Open Offer Shares for every 97 Existing
Ordinary Shares held by Qualifying Shareholders at the Record Date.
Any entitlements to Open Offer Shares not subscribed for by
Qualifying Shareholders will be available to Qualifying
Shareholders under the Excess Application Facility.
-- The net proceeds of the Capital Raising will be used to
progress the development and commercialisation of Diurnal's
products, including, inter alia:
o Progress pivotal Phase 3 studies of Efmody(R) in the US
through to registration in CAH (including a long-term follow-on
study); and
o Continue to support evolution of the Group's earlier stage
pipeline.
-- Taking into account the expected net proceeds of the Placing
and Subscription, the Group's existing and expected cash resources
and marketing approval for Alkindi(R) in both Europe and the US and
the positive opinion recently received from the European Medicines
Agency (EMA) for the approval of Efmody(R), and assuming Efmody(R)
is ultimately commercialised by a third party in the US, the Board
believes that Diurnal is funded to profitability for the Group's
late-stage cortisol replacement franchise.
-- The Issue Price represents a discount of approximately 1.4
per cent. to the mid-market closing price of the Company's Ordinary
Shares on 20 April 2021, being the last practicable date prior to
the date of this announcement.
The Board believes that the most expeditious route to
commercialisation of Efmody(R) in the US is to carry out the
pivotal US Phase 3 study in CAH itself. The Board believes this
will increase the future value of the programme, as well as
broadening the pool of potential commercialisation partners. The
Group has had positive meetings with the US Food and Drug
Administration (FDA) and expects to receive formal agreement of the
Special Protocol Assessment (SPA) for the US Phase 3 study during
Q2 2021.
As at 31 March 2021, the existing cash and cash equivalents
(unaudited) held by the Group were GBP18.0 million. In addition to
these cash resources, the Company currently holds 379,474 freely
transferable shares in Eton Pharmaceuticals Inc ("Eton") that were
received as part of the upfront consideration for the exclusive
licence agreement of Alkindi(R) Sprinkle in the US. Diurnal and
Eton are also awaiting confirmation of Orphan Drug Status of
Alkindi(R) Sprinkle from the FDA, which will trigger a $2.5 million
milestone payment to Diurnal.
The New Ordinary Shares are not being made available to the
public. It is envisaged that the Bookbuild will be closed no later
than 4.30 p.m. GMT today, 21 April 2021. Details of the number of
New Ordinary Shares and the gross proceeds of the Placing and
Subscription will be announced as soon as practicable after the
closing of the Bookbuild. The Capital Raising will not be
underwritten.
The Placing, Subscription and Open Offer are conditional upon,
amongst other things, the passing of the Resolutions to be
considered by Shareholders at the General Meeting to be held at
10.00 a.m. on 10 May 2021 at the Company's London offices at 16
Upper Woburn Place, London, WC1H 0BS, United Kingdom. The Placing
and Subscription are not conditional on the Open Offer.
Set out below in Appendix I is an adapted extract from the draft
Circular that is proposed to be sent to Shareholders after the
closure of the Bookbuild and which provides further information on
the Group, the Placing, the Subscription and Open Offer. The final
Circular, containing the terms and conditions of the Open Offer and
Notice of General Meeting will be sent to Shareholders and
published on the Company's website on or around 22 April 2021.
The capitalised terms not otherwise defined in the text of this
Announcement are defined in Appendix III and Appendix IV and the
expected timetable of the principal events is set out in Appendix
V.
Martin Whitaker, PhD, Chief Executive Officer of Diurnal,
commented:
"Having received a positive opinion for approval for Efmody(R)
from the EMA in March 2021 and, with our European launch expected
in Q3 2021, we are pleased to announce that this fundraise will
enable us to progress Efmody(R) in the US, another key market for
Diurnal. We have made excellent progress with our development plans
for a pivotal Phase 3 clinical trial in the US for Efmody(R) and,
with the proposed new funds, we expect to initiate the study during
H2 2021. In addition, successful completion of the fundraise will
allow us to continue to support the development of our earlier
stage pipeline, and is expected to ensure our late-stage cortisol
replacement franchise is funded through to profitability."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR) as it forms part of
the law of England and Wales by virtue of the European Union
(Withdrawal) Act 2018.
This summary should be read in conjunction with the full text of
the following announcement.
For further information, please visit www.diurnal.co.uk or contact:
Diurnal Group plc +44 (0)20 3727 1000
Martin Whitaker, Chief Executive Officer
Richard Bungay, Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser
and Sole Broker) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: Rupert Dearden
FTI Consulting (Investor Relations) +44 (0)20 3727 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Diurnal Group plc
Diurnal Group plc is a European, UK-headquartered, specialty
pharmaceutical company dedicated to developing hormone therapeutics
to aid lifelong treatment for rare and chronic endocrine
conditions, including congenital adrenal hyperplasia, adrenal
insufficiency, hypogonadism and hypothyroidism. Its expertise and
innovative research activities focus on circadian-based
endocrinology to yield novel product candidates in the rare and
chronic endocrine disease arena
For further information about Diurnal, please visit
www.diurnal.co.uk
Date of Preparation: 21 April 2021 Code: CORP-GB-0117
IMPORTANT NOTICES
IMPORTANT NOTICE
No action has been taken by the Company, Panmure Gordon, or any
of their respective affiliates, that would, or which is intended
to, permit a public offer of the New Ordinary Shares in any
jurisdiction or the possession or distribution of this announcement
or any other offering or publicity material relating to the New
Ordinary Shares in any jurisdiction where action for that purpose
is required. Any failure to comply with these restrictions may
constitute a violation of the securities laws of such
jurisdictions. Persons into whose possession this announcement
comes shall inform themselves about, and observe, such
restrictions.
No prospectus will be made available in connection with the
matters contained in this announcement and no such prospectus is
required (in accordance with the Prospectus Directive) to be
published.
THIS ANNOUNCEMENT, INCLUDING THE INFORMATION CONTAINED HEREIN,
IS FOR INFORMATION PURPOSES ONLY, IS NOT INTED TO AND DOES NOT
CONSTITUTE OR FORM PART OF ANY OFFER OR INVITATION TO PURCHASE OR
SUBSCRIBE FOR, UNDERWRITE, SELL OR ISSUE OR THE SOLICITATION OF AN
OFFER TO PURCHASE OR SUBSCRIBE, SELL, ACQUIRE, DISPOSE OF THE NEW
ORDINARY SHARES OR ANY OTHER SECURITY IN THE UNITED STATES OF
AMERICA, CANADA, AUSTRALIA, NEW ZEALAND, THE REPUBLIC OF SOUTH
AFRICA OR JAPAN OR IN ANY JURISDICTION IN WHICH, OR TO ANY PERSONS
TO WHOM, SUCH OFFERING, SOLICITATION OR SALE WOULD BE UNLAWFUL.
Panmure Gordon, which is authorised and regulated in the United
Kingdom by the FCA, is acting as nominated adviser and broker to
the Company in relation to the Placing, Subscription and Admission
and is not acting for any other persons in relation to the Placing,
Subscription and Admission. Panmure Gordon is acting exclusively
for the Company and for no one else in relation to the matters
described in this announcement and is not advising any other person
and accordingly will not be responsible to anyone other than the
Company for providing the protections afforded to clients of
Panmure Gordon, or for providing advice in relation to the contents
of this announcement or any matter referred to in it. The
responsibilities of Panmure Gordon as the Company's nominated
adviser under the AIM Rules for Companies and the AIM Rules for
Nominated Advisers are owed solely to London Stock Exchange plc and
are not owed to the Company or to any director or shareholder of
the Company or any other person, in respect of his decision to
acquire shares in the capital of the Company in reliance on any
part of this announcement, or otherwise.
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 Panmure Gordon or the Company or any of
their respective affiliates or any of their respective directors,
officers, employees, advisers or representatives (collectively,
"Representatives") 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 therefor is
expressly disclaimed.
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 New Ordinary Shares. Any
investment decision to buy New Ordinary Shares in the Capital
Raising must be made solely on the basis of publicly available
information, which has not been independently verified by Panmure
Gordon, and the Circular.
The price of Ordinary Shares and any income from them may go
down as well as up and investors may not get back the full amount
invested on disposal of the Ordinary Shares.
The New Ordinary Shares will not be admitted to trading on any
stock exchange other than AIM, a market operated by the London
Stock Exchange.
This announcement may contain "forward-looking statements" which
includes all statements other than statements of historical fact,
including, without limitation, those regarding the Group's
financial position, business strategy, plans and objectives of
management for future operations, or 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 Group'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. None of the Group,
Panmure Gordon, or their respective directors, officers, employees,
agents, affiliates and advisers, or any other party undertakes or
is under any duty to update this announcement or to correct any
inaccuracies in any such information which may become apparent or
to provide you with any additional information, other than any
requirements that the Group may have under applicable law. To the
fullest extent permissible by law, such persons disclaim all and
any responsibility or liability, whether arising in tort, contract
or otherwise, which they might otherwise have in respect of this
announcement. The information in this announcement is subject to
change without notice.
APPIX I
THE CAPITAL RAISING
Introduction
The Company proposes to raise up to approximately GBP 20.0
million (before expenses) through a conditional Placing of Placing
Shares and a conditional Subscription of Subscription Shares at 70
pence each. The Issue Price is a discount of 1.4 per cent. to the
closing middle market price of 71 pence per Existing Ordinary Share
on 20 April 2021 (being the last practicable date before
publication of the Announcement).
In addition, in order to provide Shareholders who have not taken
part in the Placing and Subscription with an opportunity to
participate in the proposed fundraise, the Company is providing all
Qualifying Shareholders with the opportunity to subscribe, at the
Issue Price, for an aggregate of up to 2,852,317 Open Offer Shares,
to raise up to approximately GBP2.0 million, on the basis of 2 Open
Offer Shares for every 97 Existing Ordinary Shares, at 70 pence
each payable in full on acceptance. Any entitlements to Open Offer
Shares not subscribed for by Qualifying Shareholders will be
available to Qualifying Shareholders under the Excess Application
Facility.
The Placing, Subscription and Open Offer are conditional on,
amongst other things, the passing of the Resolutions by
Shareholders at the General Meeting, notice of which is set out at
the end of the Circular. If the Resolutions are passed, the New
Ordinary Shares will be allotted and issued after the General
Meeting. Admission is expected to occur no later than 8.00 a.m. on
10 May 2021 (or such later time and/or date as Panmure Gordon and
the Company may agree, being no later than 8.00 a.m. on 24 May
2021). Neither the Placing, the Subscription, nor the Open Offer is
underwritten.
Description of Group
Diurnal is a European specialty pharmaceutical group,
headquartered in the UK, targeting patient needs in chronic
endocrine (hormonal) diseases. The Group aims to develop and
commercialise products to solve patient needs in endocrine
diseases, primarily those that result from a deficiency of cortisol
and testosterone, typically where there is either no licensed
medicine or where the Directors believe that current treatment does
not sufficiently address patients' needs.
Cortisol is an essential hormone produced by the adrenal gland.
Absence of cortisol can result in fatigue, depression and death
through adrenal crisis. The production of cortisol in the human
body follows a daily cycle (circadian rhythm), whereby production
increases from a minimum level during sleep, peaks upon waking and
gradually declines during the day. In adrenal disease, this
moderates the impact that excess androgens have on the body
throughout the day. If left unregulated for even short periods
during the day, excess androgens can affect patients' growth and
sexual development, resulting in symptoms such as short stature,
infertility, obesity and increased mortality.
The Directors believe the Group is on track to become a
world-leading endocrinology speciality pharma group focused on a c.
$9.6 billion[1] market opportunity and initially targeting a c.
$3.1 billion(1) market in cortisol deficiency. The Group is
building a life-long Adrenal Franchise through the Group's two
flagship products, Alkindi(R) (hydrocortisone granules in capsules
for opening) in Europe) / Alkindi(R) Sprinkle (hydrocortisone oral
granules) in the US and Efmody(R) (modified-release hydrocortisone
hard capsules, development name Chronocort(R)), to provide cortisol
replacement therapy for patients from birth to old age by targeting
two indications. The Group are initially targeting CAH, where
patients are born without an enzyme that is essential for cortisol
production, and subsequently, adrenal insufficiency (AI), where
patients lose the ability to produce cortisol leading to
insufficient cortisol production.
The Group is also seeking to maximise the value of its products
in the rest of the world, in particular, to address significant
opportunities for the treatment of CAH and AI in the major US (c.
$1.0 billion(1) ) market, as well as other important markets around
the world. The Group has also strengthened its pipeline with the
successful completion of the first clinical study with DITEST(TM),
its native oral testosterone replacement product, which has a
potential market of c. $5.1 billion(1) .
Product portfolio highlights
-- First product, Alkindi(R) (hydrocortisone granules in
capsules for opening), launched and generating revenues in Europe
(FY end 30 June 2020 GBP2.4m); approved and launched in US (as
Alkindi Sprinkle(R)); approved in Israel and Australia;
-- Second product, Efmody(R) (modified-release hydrocortisone
hard capsules), has received positive opinion for approval from the
European Medicines Agency with anticipated commercial launch in
Europe in Q3 2021. The net proceeds of the Capital Raising will be
used primarily for a pivotal registration study of Efmody(R) in CAH
in the US;
-- The Group has a direct sales force in key territories in
Europe and is forging commercial partnerships globally;
-- Commercial exclusivity until 2034 through a combination of
orphan drug designation (in the US and Great Britain, subject to
regulatory confirmation), regulatory pathways and patents; Third
product, DITEST(TM), is in clinical development targeting the c.
$5.1bn male hypogonadism market with abbreviated ("505(b)(2)")
route to US approval agreed; and
-- Earlier product pipeline maturing with the potential to
expand product offering through in-licensing opportunities.
Alkindi (R)
Alkindi(R) is the first product specifically designed for young
children suffering from paediatric AI and the related condition
CAH. Alkindi(R) is licensed in Europe and has been proven to be
effective and easy to administer. Diurnal's Alkindi(R)
commercialisation efforts are focused in the larger European
markets, and initially on patients aged 0-6 years where the unmet
need is highest.
The commercial roll-out of Alkindi(R) has continued into 2021.
In Europe, Alkindi(R) has now been launched by Diurnal directly in
the UK, Germany, Italy and Austria, and by its partner FrostPharma
in Sweden, Denmark, Norway and Iceland. Diurnal believes that the
health economic arguments underpinning Alkindi(R) are robust and
support pricing submissions in the remaining key European markets.
Whilst there has been significant disruption to commercialisation
efforts in 2020 and early 2021 due to the inability to access
hospitals as a result of Covid-19 pandemic lockdown measures,
Alkindi(R) sales have progressed significantly and the Group
expects strong future revenue growth for Alkindi(R) as the impact
of Covid-19 lessens. Despite these restrictions, Alkindi(R)
revenues grew by over 20% in the UK and Germany in the six months
ended 31 December 2020. In September 2020, Diurnal announced
distribution deals with Consilient Healthcare for the marketing of
Alkindi(R) (and Efmody(R)) in the Benelux (Belgium, the Netherlands
and Luxembourg) countries and with EffRx Pharmaceuticals for
Alkindi(R) in Switzerland. The Directors believe that these deals
will provide a highly effective means of maximising market access
by via established commercial organisations.
Outside of Europe, in the US, where the product is called
Alkindi(R) Sprinkle, approval from the US Food and Drug
Administration (FDA) was received at the end of September 2020 as
replacement therapy in paediatric patients with adrenocortical
insufficiency . Diurnal entered into a significant licensing
agreement for Alkindi Sprinkle with Eton in March 2020 and, in
November 2020, less than two months after FDA approval, Eton,
announced the commercial launch of the product. Eton is a
NASDAQ-listed specialty pharmaceutical company focused on
developing, acquiring and commercialising innovative products. Eton
is primarily focused on hospital and paediatric products, including
those in endocrinology. Eton is responsible for all
commercialisation activities, including pricing and reimbursement.
Eton is initially utilising product from Diurnal's European supply
chain, with an option to establish its own supply chain in the US
in the future. Eton estimates the market opportunity for Alkindi
(R) Sprinkle in the US could be in excess of $100m per annum. Under
the terms of the licensing agreement with Eton, Diurnal received a
non-refundable upfront payment of $5.0m, of which $3.5m was in cash
and $1.5m was in new Eton shares. Diurnal and Eton are awaiting
confirmation of Orphan Drug Status of Alkindi(R) Sprinkle from the
FDA, which will trigger a $2.5m milestone payment to Diurnal. In
January 2021, the licence with Eton was extended to cover
Canada.
In addition to the jurisdictions above, Diurnal's partner,
Emerge Health (now Chiesi Australia Pty Ltd, part of Chiesi
Farmaceutici S.p.A.), had received approval for Alkindi(R) in
Australia, with no age restriction, and its partner in Israel,
Medison Pharma, had received approval for Alkindi(R) in children
under 18 years of age during 2020. Launches in these territories
are expected following completion of pricing and reimbursement
activities. In February 2021, the Group also signed a distribution
license with Er-Kim to supply Alkindi(R) (and in due course
Efmody(R)) on a named patient basis in Turkey, and a licensing deal
with Citrine Medicine in China for Alkindi(R).
Diurnal continues to assess the opportunity for Alkindi(R) in
Japan and during H2 2020, the Group formulated a development and
regulatory strategy for this market. Consistent with this strategy,
a submission for regulatory protection was submitted to the
Japanese Ministry of Health, Labour and Welfare (MHLW) in 2021.
Efmody (R), (development name, Chronocort(R))
Diurnal's second product candidate, Efmody(R), provides a drug
release profile that the Group believes mimics the body's natural
cortisol circadian rhythm, which current therapies are unable to
replicate, and is designed to improve disease treatment for adults
with CAH, as measured by androgen (male sex hormone) control.
In December 2019, Diurnal submitted a marketing authorisation
application (MAA) to the European Medicines Agency (EMA) for
Efmody(R) as a treatment for adult and adolescent patients with
CAH. The MAA submission was based on detailed analysis of data from
the Group's Phase 3 study conducted in a total of 122 patients
enrolled across 11 clinical sites, the largest ever interventional
clinical trial completed in CAH, and an open-label safety extension
study for patients completing treatment in the Phase 3 study. This
extension study is assessing the impact of treatment with Efmody(R)
over an extended period, regardless of whether the patients were
initially treated with Efmody(R) or standard of care. A significant
proportion of patients eligible to enter the follow-on study did
so, and patient retention rates in this study have been high, with
a number of patients on this trial having been treated for over 42
months at the latest data cut in April 2020. Patients on this trial
have, to date, shown sustained benefit from extended Efmody(R)
treatment.
On 25 March 2021, the Committee for Medicinal Products for Human
Use (CHMP), an advisory committee of the European Medicine Agency
(EMA), issued a positive opinion to the European Commission
recommending Efmody(R) as treatment of adult and adolescent
patients (12 years and older) with CAH. The formal approval of the
marketing authorisation from the European Commission is anticipated
in June 2021, in accordance with the 67-day timeline following the
adoption of the positive opinion by the CHMP. On 15 April 2021, the
Company announced that, following feedback from the European
Committee for Orphan Medicinal Products (COMP) it was withdrawing
its application for maintenance of Orphan Drug Designation in
Europe for Efmody(R). Diurnal decided that continuing pursuit of an
Orphan Drug Designation for the drug in Europe would be likely to
cause a significant delay in its European commercial launch. The
Directors believe that Orphan Drug Designation for Efmody(R) in
Europe is not critical to the commercial potential of the product
in this market.
Reflecting the UK Medicines and Healthcare products Regulatory
Agency's (MHRA) guidance following the end of the Brexit Transition
Period, an 'in flight' MAA has been submitted to the MHRA seeking
approval for Efmody(R) in Great Britain based on the same
application submitted to the EMA. Approval from the MHRA is also
expected during Q2 2021. In parallel with the MHRA submission,
Diurnal will seek confirmation of British Orphan Drug Status for
Efmody(R) in CAH, which requires the Group to demonstrate
significant clinical benefit for the product compared to existing
therapies.
To facilitate timely commercial availability, Diurnal has
already commenced market access activities in its target European
territories, with the first commercial launch anticipated in Q3
2021. The Group intends to mirror its strategy for Alkindi(R) by
commercialising Efmody(R) itself in core European markets. The
Group is manufacturing launch stocks for Efmody(R) during the first
half of 2021, utilising many aspects of the supply chain that has
already been established for Alkindi(R).
Outside of its core European markets, Diurnal intends to make
Efmody(R) available commercially through distribution or licensing
deals with local partners who can quickly gain market access.
Diurnal has already expanded its global reach through such
agreements, entering into distribution deals with Consilient Health
for the Nordic and the Benelux countries and with Er-Kim to supply
Efmody(R)on a named patient basis in Turkey. The Group has existing
Efmody(R) distribution agreements with Chiesi in Australia and
Medison Pharma in Israel.
Outside of Europe, Diurnal continues to progress plans for
development of Efmody(R) in major markets. In the US, the FDA has
previously indicated that the registration package for CAH requires
an additional study to the European Phase 3 CAH study. Diurnal is
seeking formal agreement of the US Phase 3 protocol (DIUR-014) with
the FDA through an SPA. Following a positive Type A meeting with
the FDA in January 2021 and further written feedback from the FDA
in late March 2021 (which contained minor changes to the wording of
primary endpoint, an additional measurement of glucocorticoid dose
at 52 weeks and an updated statistical analysis plan reflecting
these suggestions), as part of the SPA process, the Group believes
that subject to receipt of formal confirmation of the SPA ,
expected during Q2 2021, the US Phase 3 protocol has now been
finalised. The Phase 3 registration study for Efmody(R) in the US
will recruit c. 150 patients with CAH randomised to either receive
Efmody(R) twice daily or twice daily standard hydrocortisone
treatment. The study is expected to commence in H2 2021. The study
will be a double-blind comparison of Efmody(R) versus standard
hydrocortisone replacement therapy in participants aged 16 years
and over with congenital adrenal hyperplasia. The primary endpoint
is biochemical responder non-inferiority of Efmody(R) versus twice
daily immediate release hydrocortisone after 52 weeks
randomised treatment. Secondary endpoints include responder
analysis to glucocorticoid dose, female and male indicators of
fertility, body weight, waist circumference and quality of life
measures. Successful completion of the pivotal study entitles
patients to enter the safety extension study (DIUR-015), in which
all patients will be provided Efmody(R). Up to 50 study centres are
anticipated to be included in the trials. A feasibility study is
currently underway in parallel with the SPA process. It is
currently estimated that registration of Efmody(R) in the US could
be achieved in 2025.
Diurnal is also planning a Phase 2 study (DIUR-010) in the US to
assess the utility of Efmody(R) in AI, which represents a sizeable
commercial opportunity in the US of c. $1bn, with a highly
favourable competitive landscape. Diurnal has developed a protocol
for this study, which it intends to commence in late 2022 to run
alongside the Phase 3 registration study in CAH. This trial is
currently anticipated to be funded from Diurnal's internal cash
resources.
DITEST (TM)
In November 2019, Diurnal announced positive headline results
from its Phase 1 proof-of-concept clinical study with DITEST(TM),
its native oral testosterone therapy for the treatment of male
hypogonadism. The estimated $5.1bn market in the US and Europe for
testosterone-based products for the treatment of hypogonadism is
dominated by topically available products, which have compliance
and safety issues, while key issues with the use of alternative,
oral modified testosterone products (testosterone undecanoate) have
been the variability in absorption and the requirement for a
high-fat meal to achieve therapeutic testosterone levels. This
Phase 1 study, which confirmed the positive findings in the Group's
successful in vivo pre-clinical studies, evaluated the
pharmacokinetics, safety and tolerability of DITEST(TM) in the
target patient group of 24 adult men with primary or secondary
hypogonadism. The primary endpoint of the trial compared the rate
and extent of absorption of testosterone from a single dose of
DITEST(TM) with a single dose of testosterone undecanoate in the
fed state in hypogonadal men. DITEST(TM) was shown to achieve
testosterone levels within the healthy young male adult normal
range after oral administration, with levels that were less
variable than testosterone undecanoate. Secondary endpoints
demonstrated that there was no impact on the rate and extent of
absorption of testosterone from DITEST(TM) whether taken with
either food or in the fasted state, representing a major difference
with testosterone undecanoate. The safety and tolerability of two
different doses of DITEST(TM) were also assessed in the study:
there were no serious adverse events in the DITEST(TM) arm of the
study, and levels of the potent testosterone derived androgen,
dihydrotestosterone (DHT), were lower than with testosterone
undecanoate.
Following these positive results, the Group consulted with the
FDA, which confirmed that DITEST(TM) can progress to an NDA via the
abbreviated 505(b)(2) route, which relies, in part, on published
literature and other non-Group studies to support a marketing
application and can significantly accelerate the time to approval,
compared to FDA-designated new chemical entities. The Group expects
to submit the DITEST(TM) investigational new drug application (IND)
in the US around the middle of 2021 and start the DITEST(TM)
multiple ascending dose study in Q3 of 2021. This dose escalation
study is fully funded. Assuming this study is successful, the FDA
indicated that a single Phase 3 study should be sufficient to
obtain approval for DITEST(TM) in the US. The Phase 3 study will be
subject to additional financing being available to the Group,
through additional equity investment, non-dilutive financing and/or
partnering arrangements.
Other pipeline
Diurnal's other early-stage pipeline products include a
modified-release T3 replacement therapy for patients with
hypothyroidism who do not respond to the current standard of care
(a potential market of $0.7bn in the US and Europe), and its novel
siRNA therapy for Cushing's disease (a market opportunity of close
to $0.5bn), a condition characterised by an excess of cortisol.
Formulation feasibility and clinical batch manufacture work is
underway. Subject to successful formulation development, the Group
anticipates starting a modified-release T3 human volunteer study
within 12 months. In addition, Diurnal regularly assesses third
party products for endocrine disorders that fit with in its
strategic vision. Additional pipeline development will be subject
to further financing being available to the Group, though
additional equity investment, non-dilutive financing and/or
partnering arrangements.
Proposed use of proceeds
The net proceeds of the Capital Raising will be used by the
Group primarily in relation to progressing the Group's pivotal
Phase 3 studies of Efmody(R) as a treatment for CAH in the US to
registration. In particular it is the Board's expectation that the
net proceeds from the Capital Raising, in addition to existing cash
resources, will be used to fund:
-- the progressions of pivotal Phase 3 studies of Efmody(R) in
the US through to registration in CAH (including a long-term
follow-on study); and
-- the continued support of the evolution of the Group's earlier stage pipeline.
Taking into account the expected net proceeds of the Placing and
Subscription, the Group's existing and expected cash resources and
marketing approval for Alkindi(R) in both Europe and the US and the
positive opinion recently received from the European Medicines
Agency for the approval of Efmody(R), and assuming Efmody(R) is
ultimately commercialised by a third party in the US, the Board
believes that Diurnal is funded to profitability for the Group's
late-stage cortisol replacement franchise.
As at 31 March 2021, the existing cash and cash equivalents
(unaudited) held by the Group were GBP18.0 million. In addition to
these cash resources, the Company currently holds 379,474 freely
transferable shares in Eton that were received as part of the
upfront consideration for the exclusive licence agreement of
Alkindi(R) Sprinkle in the US. Diurnal and Eton are also awaiting
confirmation of Orphan Drug Status of Alkindi(R) Sprinkle from the
FDA, which will trigger a $2.5 million milestone payment to
Diurnal.
Details of the Placing and Subscription
The Company intends to raise up to approximately GBP 20.0
million before expenses which will be conducted by way of a
conditional Placing and Subscription at the Issue Price, which will
be launched immediately following this Announcement in accordance
with the terms and conditions set out in Appendix II.
The Placing and Subscription are conditional, inter alia,
upon:
-- the Placing and Open Offer Agreement becoming unconditional
in all respects (save for any condition relating to Admission) and
not having been terminated in accordance with its terms prior to
Admission;
-- the passing of the Resolutions at the General Meeting (or any adjournment thereof); and
-- Admission becoming effective by no later than 8.00 a.m. on 11
May 2021 (or such later time and/or date (being no later than 8.00
a.m. on the 25 May 2021) as Panmure Gordon and the Company may
agree).
If any of the conditions above are not satisfied, the Placing
Shares and the Subscription Shares will not be issued. The Placing
and Subscription are not conditional on the Open Offer. The Placing
and Subscription are not subject to clawback in favour of
Shareholders pursuant to the Open Offer. The Placing and
Subscription are not underwritten.
The Placing Shares and Subscription Shares will be issued free
of all liens, charges and encumbrances and will, when issued and
fully paid, 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 after the date of their
issue.
Application will be made to the London Stock Exchange for the
admission of the Placing Shares and Subscription Shares to trading
on AIM. Subject to Shareholder approval of the Resolutions at the
General Meeting, it is expected that Admission will occur, and that
dealings in the Placing Shares subscribed for pursuant to the
Placing and the Subscription Shares subscribed for pursuant to the
Subscription will commence, at 8.00 a.m. on 11 May 2021, at which
time it is also expected that the Placing Shares subscribed for
pursuant to the Placing and the Subscription Shares subscribed for
pursuant to the Subscription will be enabled for settlement in
CREST.
Details of the Open Offer
Subject to the successful closing of the Bookbuild, the Company
is further proposing to raise up to approximately GBP2.0 million
before expenses by the issue of up to 2,852,317 Open Offer Shares
under the Open Offer at the Issue Price, payable in full on
acceptance. Any entitlements to Open Offer Shares not subscribed
for by Qualifying Shareholders will be available to Qualifying
Shareholders under the Excess Application Facility. The balance of
any Open Offer Shares not subscribed for under the Excess
Application Facility will not be available to the Placees under the
Placing.
Qualifying Shareholders should note that the Open Offer is not a
rights issue and therefore the Open Offer Shares which Qualifying
Shareholders do not apply for will not be sold in the market for
the benefit of Qualifying Shareholders who do not apply for Open
Offer Shares. The Application Form is not a document of title and
cannot be traded or otherwise transferred.
Qualifying Shareholders may apply for Open Offer Shares under
the Open Offer at the Issue Price pro rata to their holdings of
Existing Ordinary Shares on the Record Date on the basis of:
2 Open Offer Shares for every 97 Existing Ordinary Shares
Entitlements of Qualifying Shareholders will be rounded down to
the nearest whole number of Open Offer Shares. Fractional
entitlements which would otherwise arise will not be issued to the
Qualifying Shareholders but will be aggregated and made available
under the Excess Application Facility. Not all Shareholders will be
Qualifying Shareholders. Shareholders who are located in, or are
citizens of, or have a registered office in a Restricted
Jurisdiction will not qualify to participate in the Open Offer. The
attention of Overseas Shareholders is drawn to paragraph 7 of Part
3 of the Circular.
Subject to availability, the Excess Application Facility enables
Qualifying Shareholders to apply for Excess Shares up to the
maximum number of Open Offer Shares available less their Open Offer
Entitlement, subject to availability. Further details of the Open
Offer and the Excess Application Facility are given in Part 3 of
the Circular.
Valid applications by Qualifying Shareholders will be satisfied
in full up to their Open Offer Entitlements. Applicants can apply
for less or more than their entitlements under the Open Offer, but
the Company cannot guarantee that any application for Excess Shares
under the Excess Application Facility will be satisfied, as this
will depend, in part, on the extent to which other Qualifying
Shareholders apply for less than or more than their own Open Offer
Entitlements. The Company may satisfy valid applications for Excess
Shares in whole or in part but reserves the right not to satisfy
any application above any Open Offer Entitlement. The Board may
scale back applications made in excess of Open Offer Entitlements
on such basis as it reasonably considers to be appropriate.
Application has been made for the Open Offer Entitlements and
Excess CREST Open Offer Entitlements to be admitted to CREST. It is
expected that such Open Offer Entitlements and Excess CREST Open
Offer Entitlements will be credited to CREST on 23 April 2021. The
Open Offer Entitlements and Excess CREST Open Offer Entitlements
will be enabled for settlement in CREST until 11.00 a.m. on 7 May
2021. Applications through the CREST system may only be made by the
Qualifying CREST Shareholder originally entitled or by a person
entitled by virtue of bona fide market claims. The Open Offer
Shares must be paid in full on application. The latest time and
date for receipt of completed Application Forms or CREST
applications and payment in respect of the Open Offer is 11.00 a.m.
on 7 May 2021.
The Open Offer Shares must be paid for in full on application.
Further details of the Open Offer and the terms and conditions on
which it is being made, including the procedure for application and
payment, are contained in Part 3 of the Circular and, where
relevant, on the accompanying Application Form.
The Open Offer is conditional on the Placing and Subscription
becoming or being declared unconditional in all respects and not
being terminated before Admission. The other principal conditions
to the Open Offer are:
a. the passing of all of the Resolutions at the General Meeting;
b. the Placing and Open Offer Agreement having become or being
declared unconditional and not having been terminated before
Admission; and
c. Admission becoming effective by no later than 8.00 a.m. on 11
May 2021 (or such later time and/or date (being not later than 8.00
a.m. on 25 May 2021) as the Company, Panmure Gordon may agree).
Accordingly, if those conditions are not satisfied or waived
(where capable of waiver), the Open Offer will not proceed and the
Open Offer Shares will not be issued and all monies received by
Link Group in respect of the Open Offer will be returned to the
applicants (at the applicants' risk and without interest) as soon
as possible thereafter and any Open Offer Entitlements and Excess
CREST Open Offer Entitlements in relation to Open Offer Shares
admitted to CREST will thereafter be disabled. In this
circumstance, the Company will not receive the relevant net
proceeds in respect of the issue of the Open Offer Shares and
monies paid by Qualifying Shareholders in respect of subscriptions
for Open Offer Shares will be returned.
The Open Offer Shares will be issued free of all liens, charges
and encumbrances and will, when issued and fully paid, rank pari
passu in all respects with the Existing Ordinary Shares and the
Placing Shares and Subscription Shares, including the right to
receive all dividends and other distributions declared, made or
paid after the date of their issue.
The Placing and Open Offer Agreement
Pursuant to the Placing and Open Offer Agreement, Panmure Gordon
has agreed to use its reasonable endeavours, as agent of the
Company, to procure subscribers for the Placing Shares at the Issue
Price.
Panmure Gordon's obligations under the Placing and Open Offer
Agreement are conditional on, amongst other things:
-- Admission occurring at or before 8.00 a.m. on 11 May 2021 (or
such later time and/or date (being not later than 8.00 a.m. on 25
May 2021) as the Company and Panmure Gordon may agree);
-- the compliance by the Company with all of its obligations
under the Placing and Open Offer Agreement to the extent they are
required to be performed on or prior to Admission;
-- the Resolutions being approved by the required majorities of
Shareholders attending and voting (in person or by proxy) at the
General Meeting at which they are proposed; and
-- the obligations of Panmure Gordon not having been terminated,
so far as the same fall to be performed prior to Admission.
The Placing and Subscription are not conditional on the Open
Offer.
If: (i) any condition contained in the Placing and Open Offer
Agreement in relation to the Placing Shares is not fulfilled or
waived (to the extent capable of being waived) by Panmure Gordon,
by the respective time or date where specified; (ii) any such
condition becomes incapable of being fulfilled; or (iii) the
Placing and Open Offer Agreement is terminated in accordance with
its terms, the Placing and Subscription will not proceed and the
Placees' or subscribers' rights and obligations thereunder in
relation to the Placing Shares and Subscription Shares shall cease
and terminate at such time and each Placee or subscriber agrees
that no claim can be made by the Placee in respect thereof. The
Placing and Open Offer Agreement provides, amongst other things,
for payment by the Company to Panmure Gordon of certain commissions
and fees in connection with its appointment.
The Company will bear all other expenses of and incidental to
the Capital Raising, including the fees of the London Stock
Exchange, printing costs, registrar's fees, all properly incurred
legal and accounting fees of the Company, Panmure Gordon and any
other taxes and duties payable.
The Placing and Open Offer Agreement contains customary
warranties and indemnities from the Company in favour of Panmure
Gordon.
Panmure Gordon may (after consultation with the Company)
terminate the Placing and Open Offer Agreement prior to Admission
in certain circumstances, if, amongst other things, the Company is
in material breach of any of its obligations under the Placing and
Open Offer Agreement (including the warranties contained in the
Placing and Open Offer Agreement), if there is a material adverse
change in the condition, earnings, business, operations or solvency
of the Group or if there is a material adverse change in the
financial, political, economic or stock market conditions, which in
Panmure Gordon's reasonable opinion (acting in good faith) makes it
impractical or inadvisable to proceed with the Capital Raising.
Directors' Participation
Certain Directors in the Company intend to subscribe for New
Ordinary Shares in connection with the Capital Raising. The number
of Subscription Shares the Directors intend to subscribe for
pursuant to the Capital Raising, are set out below:
Shareholder Number of Subscription
Shares intended
to be subscribed
for
Sam Williams(*) 28,571
Richard Bungay 7,143
John Goddard 28,571
*Director nominated by IP Group plc
In addition to the above, Martin Whitaker intends to subscribe
for 10,000 New Ordinary Shares pursuant to the Open Offer.
General Meeting
The Directors do not currently have authority to allot all the
New Ordinary Shares and, accordingly, the Board is seeking the
approval of Shareholders to allot the New Ordinary Shares at the
General Meeting.
Recommendation
The Directors believe that the Placing, Subscription and the
Open Offer and the passing of the Resolutions are in the best
interests of the Company and the Shareholders, taken as a whole.
The Directors unanimously recommend the Shareholders to vote in
favour of the Resolutions as they intend to do in respect of their
own holdings of Ordinary Shares, amounting in aggregate to
3,274,225 Existing Ordinary Shares (representing approximately 2.37
per cent. of the Existing Ordinary Shares).
APPIX II
TERMS AND CONDITIONS OF THE PLACING
INTRODUCTION
IMPORTANT INFORMATION FOR INVITED PLACEES ONLY REGARDING THE
PLACING.
THIS ANNOUNCEMENT, INCLUDING THIS APPIX, AND THE INFORMATION IN
IT, IS RESTRICTED, AND IS NOT FOR PUBLICATION, RELEASE OR
DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART TO U.S.
PERSONS OR, IN OR INTO THE UNITED STATES, THE RESTRICTED
JURISDICTION OR ANY OTHER JURISDICTION IN WHICH SUCH PUBLICATION OR
DISTRIBUTION WOULD BE UNLAWFUL.
THE PLACING SHARES THAT ARE THE SUBJECT OF THE PLACING ARE NOT
BEING OFFERED OR SOLD TO ANY PERSON IN THE EUROPEAN ECONOMIC AREA
("EEA") OR THE UK, OTHER THAN TO QUALIFIED INVESTORS WITHIN THE
MEANING OF ARTICLE 2(E) OF THE PROSPECTUS REGULATION (EU) 2017/1129
("EU PROSPECTUS REGULATION") OR WITHIN THE MEANING OF ARTICLE 2(E)
OF THE PROSPECTUS REGULATION (EU) 2017/1129 AS IT FORMS PART OF THE
LAW OF ENGLAND AND WALES BY VIRTUE OF THE EUROPEAN UNION
(WITHDRAWAL) ACT 2018 ("UK PROSPECTUS REGULATION"), WHICH INCLUDES
LEGAL ENTITIES WHICH ARE REGULATED BY THE FCA OR ENTITIES WHICH ARE
NOT SO REGULATED WHOSE CORPORATE PURPOSE IS SOLELY TO INVEST IN
SECURITIES.
MEMBERS OF THE PUBLIC IN THE UK OR ELSEWHERE ARE NOT ELIGIBLE TO
TAKE PART IN THE PLACING. THIS ANNOUNCEMENT (INCLUDING THIS APPIX)
AND THE TERMS AND CONDITIONS SET OUT HEREIN ARE FOR INFORMATION
PURPOSES ONLY AND ARE DIRECTED ONLY AT: (A) PERSONS WHO ARE
QUALIFIED INVESOTRS WITHIN THE MEANING OF ARTICLE 2(E) OF THE EU
PROSPECTUS REGULATION ("EU QUALIFIED INVESTORS"); OR (B) PERSONS IN
THE UNIKTED KINGDOM WHO ARE QUALIFIED INVESTORS WITHIN THE MEANING
OF ARTICLE 2(E) OF THE UK PROSPECTUS REGULATION ("UK QUALIFIED
INVESTORS") WHO ALSO
(I) FALL WITHIN ARTICLE 19(5) OF THE FINANCIAL PROMOTION ORDER,
OR (II) FALL WITHIN ARTICLE 49(2)(A) TO (D) OF THE FINANCIAL
PROMOTION ORDER; OR ARE PERSONS TO WHOM IT MAY OTHERWISE BE
LAWFULLY COMMUNICATED AND (III) ARE A "PROFESSIONAL CLIENT" OR AN
"ELIGIBLE COUNTERPARTY" WITHIN THE MEANING OF CHAPTER 3 OF THE
FCA'S CONDUCT OF BUSINESS SOURCEBOOK; OR (C) OTHER PERSONS TO WHOM
IT MAY LAWFULLY BE COMMUNICATED (ALL SUCH PERSONS TOGETHER BEING
REFERRED TO AS "RELEVANT PERSONS"). THIS ANNOUNCEMENT (INCLUDING
THIS APPIX) AND THE TERMS AND CONDITIONS SET OUT HEREIN MUST NOT BE
ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY
INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT
(INCLUDING THIS APPIX) AND THE TERMS AND CONDITIONS SET OUT HEREIN
RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED
IN ONLY WITH RELEVANT PERSONS.
THIS ANNOUNCEMENT, INCLUDING THIS APPIX, IS NOT AN OFFER FOR
SALE OR SUBSCRIPTION IN ANY JURISDICTION IN WHICH SUCH OFFER,
SOLICITATION OR SALE WOULD BE UNLAWFUL UNDER THE SECURITIES LAWS OF
ANY SUCH JURISDICTION. THIS ANNOUNCEMENT, INCLUDING THIS APPIX, IS
NOT AN OFFER OF OR SOLICITATION TO PURCHASE OR SUBSCRIBE FOR
SECURITIES IN THE UNITED STATES.
EACH PLACEE SHOULD CONSULT WITH ITS OWN ADVISERS AS TO LEGAL,
TAX, BUSINESS AND RELATED ASPECTS OF AN INVESTMENT IN PLACING
SHARES. THE PRICE OF THE PLACING SHARES IN THE COMPANY AND THE
INCOME FROM THEM (IF ANY) MAY GO DOWN AS WELL AS UP AND INVESTORS
MAY NOT GET BACK THE FULL AMOUNT INVESTED ON DISPOSAL OF THE
PLACING SHARES.
Placees will be deemed to have read and understood this
announcement and these terms and conditions in their entirety and
to be making such offer on the terms and conditions and to be
providing the representations, warranties, acknowledgements, and
undertakings contained in this Appendix. In particular, each such
Placee represents, warrants and acknowledges 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 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
have not been acquired on behalf of, nor have they been acquired
with a view to their offer or resale to, persons in any Member
State of the EEA or the UK other than EU Qualified Investors under
Article 2(e) the EU Prospectus Regulation, or UK Qualified
Investors or in circumstances in which the prior consent of Panmure
Gordon has been given to the offer or resale; or (ii) where Placing
Shares have been acquired by it on behalf of persons in any Member
State of the EEA or the UK other than EU Qualified Investors or UK
Qualified Investors, the offer of those Placing Shares to it is not
treated under the Prospectus Regulation as having been made to such
persons; and/or
3. (i) (1) it is not a U.S. Person, (2) it is not located in the
United States, and (3) it is not acquiring the Placing Shares for
the account or benefit of a U.S. Person; or (ii) it is a dealer or
other professional fiduciary in the United States acting for a
discretionary account (other than an estate or trust) held for the
benefit or account of a non U.S. person in reliance on Regulation
S.
The Company and Panmure Gordon will rely upon the truth and
accuracy of the foregoing representations, acknowledgements and
agreements. Panmure Gordon does not make any representation to any
Placee regarding an investment in the Placing Shares referred to in
this announcement (including this Appendix).
This announcement (including this Appendix) does not constitute
an offer, and may not be used in connection with an offer, to sell
or issue or the solicitation of an offer to buy or subscribe for
Placing Shares in any jurisdiction in which such offer or
solicitation is or may be unlawful. This announcement (including
this Appendix) and the information contained herein is not for
publication or distribution, directly or indirectly, to persons in
the United States, the Restricted Jurisdiction or in any
jurisdiction in which such publication or distribution is unlawful.
Persons who come into possession of this announcement are required
by the Company to inform themselves about and to observe any
restrictions of transfer of this announcement. No public offer of
securities of the Company under the Placing is being made in the
United Kingdom, the United States or any Restricted
Jurisdiction.
In particular, the Placing Shares referred to in this
announcement have not been and will not be registered under the
Securities Act or under any laws of, or with any securities
regulatory authority of, any state or other jurisdiction of the
United States, and may not be offered, sold, resold, transferred or
delivered, directly or indirectly, in the United States or to, or
for the account or benefit of, U.S. Persons, except pursuant to an
exemption from, or in a transaction not subject to, the
registration requirements of the Securities Act and in compliance
with any applicable securities laws of any state or other
jurisdiction in the United States, and under circumstances that
would not result in the Company being in violation of the U.S.
Investment Company Act. The Placing Shares are only being offered
and sold outside the United States in offshore transactions to
persons who are not U.S. Persons in accordance with Regulation S
under the Securities Act.
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; 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 any of the Restricted Jurisdiction. 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 the Restricted
Jurisdiction or any other jurisdiction outside the United
Kingdom.
Persons (including, without limitation, nominees and trustees)
who have a contractual or other legal obligation to forward a copy
of this Appendix or the announcement of which it forms part should
seek appropriate advice before taking any action.
DETAILS OF THE PLACING
Panmure Gordon has entered into the Placing and Open Offer
Agreement with the Company under which Panmure Gordon has, on the
terms and subject to the conditions set out therein, undertaken to
use its reasonable endeavours to procure, as agent for the Company,
subscribers for the Placing Shares at the Issue Price.
The Placing and Open Offer Agreement contains customary
warranties given by the Company to Panmure Gordon as to matters
relating to the Company and its business and a customary indemnity
given by the Company Panmure Gordon in respect of liabilities
arising out of, or in connection with, the Placing.
Panmure Gordon (after consultation with the Company) reserves
the right to scale back the number of Placing Shares to be
subscribed by any Placee in the event of applications in excess of
the target amount under the Placing. The Company and Panmure Gordon
also reserve the right not to accept offers to subscribe for
Placing Shares or to accept such offer in part rather than in
whole. Panmure Gordon shall be entitled to effect the Placing by
such method as it shall in its sole discretion determine. To the
fullest extent permissible by law, neither Panmure Gordon nor any
holding company of Panmure Gordon nor any subsidiary branch or
affiliate of Panmure Gordon (each an affiliate) nor any person
acting on behalf of any of the foregoing shall have any liability
to the Placees (or to any other person whether acting on behalf of
a Placee or otherwise). In particular, neither Panmure Gordon, nor
any affiliate thereof nor any person acting on their behalf shall
have any liability to Placees in respect of their conduct of the
Placing.
Each Placee's obligations will be owed to the Company and to
Panmure Gordon. Following the confirmation referred to below in the
paragraph entitled "Participation in, and principal terms of, the
Placing", each Placee will also have an immediate, separate,
irrevocable and binding obligation, owed to Panmure Gordon, to pay
to Panmure Gordon (or as Panmure Gordon may direct) in cleared
funds an amount equal to the product of the Issue Price and the
number of Placing Shares which such Placees has agreed to
acquire.
Each Placee agrees to indemnify on demand and hold each of
Panmure Gordon and the Company, and their respective affiliates
harmless from any all costs, claims, liabilities and expenses
(including legal fees and expenses) arising out of or in connection
with any breach of the acknowledgments, undertakings,
representations, warranties and agreements set forth in these terms
and conditions and any contract note.
The Placing is also conditional upon the Placing and Open Offer
Agreement becoming unconditional and the Placing and Open Offer
Agreement not being terminated in accordance with its terms.
Further details of conditions in relation to the Placing are set
out below in the paragraph entitled "Conditions of the
Placing".
A Placee agrees to become a member of the Company and agrees to
subscribe for those Placing Shares allocated to it by Panmure
Gordon at the Issue Price, conditional on: (i) Admission occurring
and becoming effective by 8.00 a.m. on 11 May 2021 (or, such later
time and/or date, not being later than 8.00 a.m. on 25 May 2021, as
the Company and Panmure Gordon may agree); (ii) the Placing and
Open Offer Agreement becoming otherwise unconditional in all
relevant respects and not having been terminated in accordance with
its terms on or before the date of Admission; and (iii) Panmure
Gordon confirming to the Placees their allocation of Placing
Shares.
To the fullest extent permitted by law, each Placee acknowledges
and agrees that it will not be entitled to exercise any remedy of
rescission at any time. This does not affect any other rights the
Placee may have.
APPLICATION FOR ADMISSION TO TRADING
Application will be made to the London Stock Exchange for
Admission. It is expected that settlement of the Placing Shares and
Admission will become effective on or around 8.00 a.m. on 11 May
2021 and that dealings in the Placing Shares will commence at that
time.
PAYMENT FOR SHARES
Each Placee has a separate, irrevocable and binding obligation
to pay the Issue Price in cleared funds for the number of Placing
Shares duly allocated to the Placee under the Placing in the manner
and by the time directed by Panmure Gordon. If any Placee fails to
pay as so directed and/or by the time directed, the relevant
Placee's application for Placing Shares shall at Panmure Gordons'
discretion either be rejected or accepted in which case the
paragraph below entitled "Registration and Settlement" shall apply
to such application.
PARTICIPATION IN, AND PRINCIPAL TERMS OF, THE PLACING
Panmure Gordon (whether through itself or any of its affiliates)
is arranging the Placing as placing agent of the Company for the
purpose of using reasonable endeavours to procure Placees at the
Issue Price for the Placing Shares.
Participation in the Placing will only be available to persons
who may lawfully be, and are, invited to participate by Panmure
Gordon. Panmure Gordon and its affiliates may participate in the
Placing as principal.
By participating in the Placing, Placees will be deemed to have
read and understood this announcement, including this Appendix, in
its entirety and to be participating and making an offer for
Placing Shares on the terms and conditions, and to be providing the
representations, warranties, acknowledgements, agreements and
undertakings contained in this Appendix.
This Appendix 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 number of Placing Shares to be issued, and the extent of
each Placee's participation in the Placing (which will not
necessarily be the same for each Placee), will be agreed by Panmure
Gordon, (following consultation with the Company) following
completion of the bookbuilding process in respect of the Placing
(the "Bookbuild"). No element of the Placing will be underwritten.
The aggregate number of Placing Shares will be announced on a
Regulatory Information Service following completion of the
Bookbuild.
A Placee's commitment to acquire a fixed number of Placing
Shares under the Placing will be agreed orally with Panmure Gordon
as agent of the Company. Each Placee's allocation will be confirmed
to Placees orally or by email by Panmure Gordon, and a form of
confirmation will be dispatched as soon as possible thereafter. The
oral or email confirmation to such Placee will constitute an
irrevocable legally binding commitment upon such person (who will
at that point become a Placee) in favour of Panmure Gordon and the
Company, under which it agrees to acquire the number of Placing
Shares allocated to it at the Issue Price on the terms and
conditions set out in this Appendix and in accordance with the
articles of incorporation of the Company.
Except as required by law or regulation, no press release or
other announcement will be made by Panmure Gordon or the Company
using the name of any Placee (or its agent), in its capacity as
Placee (or agent), other than with such Placee's prior written
consent.
Irrespective of the time at which a Placee's allocation pursuant
to the Placing is confirmed, settlement for all Placing Shares to
be acquired pursuant to the Placing will be required to be made on
the basis explained below under the paragraph entitled
"Registration and Settlement".
All obligations under the Placing will be subject to fulfilment
or (where applicable) waiver of, amongst other things, the
conditions referred to below and to the Placing not being
terminated on the basis referred to below.
By participating in the Placing, each Placee will agree 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.
To the fullest extent permissible by law, none of the Company,
Panmure Gordon or any of its respective affiliates shall have any
liability to Placees (or to any other person whether acting on
behalf of a Placee or otherwise under these terms and conditions).
In particular, none of the Company, Panmure Gordon or any of its
respective affiliates shall have any liability (including to the
fullest extent permissible by law, any fiduciary duties) in respect
of Panmure Gordons's conduct of the Placing. Each Placee
acknowledges and agrees that the Company is responsible for the
issue of the Placing Shares to the Placees and Panmure Gordon shall
have no liability to the Placees for the failure of the Company to
fulfil those obligations.
CONDITIONS OF THE PLACING
The Placing is conditional upon the Placing and Open Offer
Agreement becoming unconditional and not having been terminated in
accordance with its terms.
Panmure Gordon's obligations under the Placing and Open Offer
Agreement in respect of the Placing Shares are conditional on,
inter alia:
1. the Company allotting, subject only to Admission, the Placing
Shares in accordance with the Placing and Open Offer Agreement;
2. Admission taking place not later than 8.00 a.m. on 11 May
2021 (or such later date as may be agreed in writing between the
Company and Panmure Gordon);
3. the Company having complied with its obligations under the
Placing and Open Offer Agreement; and
4. the passing of the Resolutions to be proposed at the general
meeting of the Company to be held on or around 10 May 2021, or any
adjournment thereof.
If (a) any of the conditions contained in the Placing and Open
Offer Agreement in relation to the Placing Shares are not fulfilled
or waived by Panmure Gordon by the respective time or date where
specified (or such later time or date as the Company and Panmure
Gordon may agree not being later than 5.00 p.m. on the "Final
Date"); or (b) the Placing and Open Offer Agreement is terminated
as described below, the Placing in relation to the Placing Shares
will lapse and the Placee's 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 the Placee
in respect thereof.
Subject to certain exceptions, Panmure Gordon may, at its
absolute discretion and upon such terms as it thinks fit, waive, or
extend the period (up to the Final Date) for, compliance by the
Company with the whole or any part of any of the Company's
obligations in relation to the conditions in the Placing and Open
Offer Agreement. Any such extension or waiver will not affect
Placees' commitments as set out in this announcement.
Neither Panmure Gordon nor the Company 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 condition to the Placing nor for any decision
they may make as to the satisfaction of any condition or in respect
of the Placing generally and by participating in the Placing each
Placee agrees that any such decision is within the absolute
discretion of Panmure Gordon.
RIGHT TO TERMINATE UNDER THE PLACING AND OPEN OFFER
AGREEMENT
Panmure Gordon is entitled, at any time before Admission, to
terminate the Placing and Open Offer Agreement by giving notice to
the Company in certain circumstances, including, inter alia:
1. the Company has failed to comply with any of its obligations
under the Placing and Open Offer Agreement which is material in the
context of the Placing and/or Admission; or
2. any of the warranties given by the Company to Panmure Gordon
under the Placing and Open Offer Agreement not being true or
accurate or being misleading when given or deemed given or repeated
or deemed repeated (by reference to the facts and circumstances in
each case then existing) in a respect which is material in the
context of the Placing and/or Admission; or
3. if, amongst other things, there is a material adverse change
in the condition, earnings, business, operations or prospects of
the Group or if there is a material adverse change in the
financial, political, economic or stock market conditions, which in
the Panmure Gordon's reasonable opinion (acting in good faith)
makes it impractical or inadvisable to proceed with the Placing
Following Admission, the Placing and Open Offer Agreement is not
capable of termination to the extent that it relates to the Placing
of the Placing Shares.
The rights and obligations of the Placees shall terminate only
in the circumstances described in these terms and conditions and in
the Placing and Open Offer Agreement and will not be subject to
termination by the Placee or any prospective Placee at any time or
in any circumstances. By participating in the Placing, Placees
agree that the exercise by Panmure Gordon of any right of
termination or other discretion under the Placing and Open Offer
Agreement shall be within the absolute discretion of Panmure Gordon
and that it need not make any reference to Placees and that it
shall have no liability to Placees whatsoever in connection with
any such exercise or decision not to exercise. Placees will have no
rights against Panmure Gordon, the Company or any of their
respective directors or employees under the Placing and Open Offer
Agreement pursuant to the Contracts (Rights of Third Parties) Act
1999 (as amended).
NO PROSPECTUS
The Placing Shares are being offered to Relevant Persons only
and will not be offered in such a way as to require a prospectus in
the United Kingdom or elsewhere. No offering document or prospectus
has been or will be submitted to be approved by the FCA in relation
to the Placing and Placees' commitments will be made solely on the
basis of the information contained in this announcement (including
this Appendix) and certain business and financial information the
Company is required to publish in accordance with the AIM Rules and
the rules and practices of the FCA (collectively "Exchange
Information").
Each Placee, by accepting a participation in the Placing, agrees
that the content of this announcement, including this Appendix, is
exclusively the responsibility of the Company and confirms that it
has not relied on any other information (other than the Exchange
Information), representation, warranty, or statement made by or on
behalf of the Company or Panmure Gordon or any other person and
neither Panmure Gordon nor the Company nor any other person will be
liable for any Placee's decision to participate in the Placing
based on any other information, representation, warranty or
statement which the Placees may have obtained or received. 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. Nothing in
this paragraph shall exclude the liability of any person for
fraudulent misrepresentation.
REGISTRATION AND SETTLEMENT
Settlement of transactions in the Placing Shares (ISIN:
GB00BDB6Q760) following Admission will take place within CREST
provided that, subject to certain exceptions, Panmure Gordon
reserves the right to require settlement for, and delivery of, the
Placing Shares (or a portion thereof) to Placees by such other
means that they deem necessary if delivery or settlement is not
possible or practicable within CREST within the timetable set out
in this announcement or would not be consistent with the regulatory
requirements in any Placee's jurisdiction.
Each Placee allocated Placing Shares in the Placing will be sent
a form of confirmation stating the number of Placing Shares
allocated to it at the Issue Price, the aggregate amount owed by
such Placee to Panmure Gordon (as agent for the Company) and
settlement instructions (including the trade date which will be 5
May 2021). Each Placee agrees that it will do all things necessary
to ensure that delivery and payment is completed in accordance with
either the CREST or certificated settlement instructions that it
has in place with Panmure Gordon. Each Placee will also be sent a
trade confirmation on the trade date (referred to above) confirming
the details of the trade (being the acquisition of the relevant
number of Placing Shares).
Settlement of transactions in the Placing Shares (ISIN:
GB00BDB6Q760) following Admission will take place within the CREST
system, subject to certain exceptions. Settlement through CREST of
the Placing Shares is expected to take place on 11 May 2021 unless
otherwise notified by Panmure Gordon and Admission is expected to
occur no later than 8.00 a.m. on 25 May 2021 unless otherwise
notified by Panmure Gordon.
Admission and settlement may occur at an earlier date.
Settlement will be on a delivery versus payment basis. However, in
the event of any difficulties or delays in the admission of the
Placing Shares to CREST or the use of CREST in relation to the
Placing, the Company and Panmure Gordon may agree that the Placing
Shares should be issued in certificated form. Panmure Gordon
reserve the right to require settlement for the Placing Shares, and
to deliver the Placing Shares to Placees, by such other means as
they deem necessary if delivery or settlement to Placees is not
practicable within the CREST system or would not be consistent with
regulatory requirements in a Placee's jurisdiction.
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 Libor as
determined by Panmure Gordon.
Each Placee is deemed to agree that, if it does not comply with
these obligations, Panmure Gordon may sell any or all of the
Placing Shares allocated to that Placee on such Placee's behalf and
retain from the proceeds, for Panmure Gordon's account and benefit
(as agent for the Company), an amount equal to the aggregate amount
owed by the Placee plus any interest due. Any excess proceeds will
pass to the relevant Placee at its risk. The relevant Placee will,
however, remain liable and shall indemnify Panmure Gordon on demand
for any shortfall below the aggregate amount owed by it and may be
required to bear any stamp duty or stamp duty reserve tax or
securities transfer tax (together with any interest or penalties)
which may arise upon the sale of such Placing Shares on such
Placee's behalf. By communicating a bid for Placing Shares, each
Placee confers on Panmure Gordon all such authorities and powers
necessary to carry out any such sale and agrees to ratify and
confirm all actions which Panmure Gordon lawfully takes in
pursuance of such sale.
If Placing Shares are to be delivered to a custodian or
settlement agent, Placees should ensure that the form of
confirmation is copied and delivered immediately to the relevant
person within that organisation.
Insofar as Placing Shares are registered 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
or securities transfer tax. Placees will not be entitled to receive
any fee or commission in connection with the Placing.
REPRESENTATIONS, WARRANTIES AND FURTHER TERMS
By participating in the Placing, each Placee (and any person
acting on such Placee's behalf) makes the following
representations, warranties, acknowledgements, agreements and
undertakings (as the case may be) to the Company and Panmure
Gordon, namely that, each Placee (and any person acting on such
Placee's behalf):
1. represents and warrants that it has read and understood this
announcement, including this Appendix, in its entirety and that its
subscription of Placing Shares is subject to, and based upon, all
the terms, conditions, representations, warranties,
acknowledgements, agreements and undertakings and other information
contained herein and undertakes not to redistribute or duplicate
this announcement (including this Appendix);
2. acknowledges that no offering document or prospectus has been
prepared in connection with the placing of the Placing Shares and
represents and warrants that it has not received a prospectus or
other offering document in connection therewith;
4. acknowledges that the Placing Shares are admitted to trading
on AIM, and the Company is therefore required to publish Exchange
Information, which includes a description of the nature of the
Company's business and the Company's most recent balance sheet and
profit and loss account and that the Placee is able to obtain or
access such information without undue difficulty, and is able to
obtain access to such information or comparable information
concerning any other publicly traded company, without undue
difficulty;
5. acknowledges that the content of this announcement (including
this Appendix) is exclusively the responsibility of the Company,
and that neither Panmure Gordon, its affiliates or any person
acting on their behalf has or shall have any liability for any
information, representation or statement contained in this
announcement (including this Appendix) or any information
previously or concurrently published by or on behalf of the Company
(including any Exchange Information), and will not be liable for
any Placee's decision to participate in the Placing based on any
information, representation or statement contained in this
announcement (including this Appendix) or otherwise. Each Placee
further represents, warrants and agrees that the only information
on which it is entitled to rely and on which such Placee has relied
in committing itself to acquire the Placing Shares is contained in
this announcement (including this Appendix) and any Exchange
Information, such information being all that it deems necessary to
make an investment decision in respect of the Placing Shares and
that it has neither received nor relied on any other information
given or
representations, warranties or statements made by Panmure Gordon
or the Company or any of their respective directors, officers or
employees or any person acting on behalf of any of them (including
with respect to the Company, the Placing, the Placing Shares or the
accuracy, completeness or adequacy of any publicly available
information), or, if received, it has not relied upon any such
information, representations, warranties or statements, and neither
Panmure Gordon nor the Company will be liable for any Placee's
decision to accept an invitation to participate in the Placing
based on any other information, representation, warranty or
statement. Each Placee further acknowledges and agrees that it may
not place the same degree of reliance on this announcement as it
may otherwise place on a prospectus or admission document. Each
Placee further acknowledges and agrees that it has relied solely on
its own investigation of the business, financial or other position
of the Company and the terms of the Placing in deciding to
participate in the Placing and it will not rely on any
investigation that Panmure Gordon, its affiliates or any other
person acting on their behalf has or may have conducted;
6. represents and warrants that it has neither received nor
relied on any confidential price sensitive information concerning
the Company in accepting this invitation to participate in the
Placing;
7. acknowledges that Panmure Gordon does not have any duties or
responsibilities to it, or its clients, similar or comparable to
the duties of "best execution" and "suitability" imposed by the
Conduct of Business Sourcebook in the FCA's Handbook of Rules and
Guidance and that Panmure Gordon is not acting for it or its
clients and that Panmure Gordon will not be responsible for
providing protections to it or its clients;
8. acknowledges that neither Panmure Gordon, any of its
affiliates or any person acting on behalf of them has or shall have
any liability for any publicly available or filed information
(including any Exchange Information) or any representation relating
to the Company, provided that nothing in this paragraph excludes
the liability of any person for fraudulent misrepresentation made
by that person;
9. that, save in the event of fraud on the part of Panmure
Gordon (and to the extent permitted by the FCA), neither Panmure
Gordon, its respective ultimate holding companies nor any direct or
indirect subsidiary undertakings of such holding companies, nor any
of their respective directors and employees shall be liable to
Placees for any matter arising out of Panmure Gordon's role as
placing agent or otherwise in connection with the Placing and that
where any such liability nevertheless arises as a matter of law,
Placees will immediately waive any claim against any of such
persons which it may have in respect thereof;
10. represents and warrants that a) (i) it is not in the United
States; (ii) it is not a U.S. Person; and (iii) it is not acting
for the account or benefit of a U.S. Person or b) it is a dealer or
other professional fiduciary in the United States acting for a
discretionary account (other than an estate or trust) held for the
benefit or account of a non U.S. Person in reliance on Regulation
S;
11. acknowledges that the Placing Shares are only being offered
and sold outside the United States in offshore transactions to
persons who are not U.S. Persons pursuant to Regulation S under the
Securities Act, and the Placing Shares have not been and will not
be registered under the Securities Act or under any laws of, or
with any securities regulatory authority of, any state or other
jurisdiction of the United States, and agrees not to reoffer,
resell, pledge, transfer or deliver any Placing Shares, directly or
indirectly, in the United States or to, or for the account or
benefit of, U.S. Persons, except pursuant to an exemption from, or
in a transaction not subject to, the registration requirements of
the Securities Act and in compliance with any applicable securities
laws of any state or other jurisdiction in the United States;
12. unless otherwise specifically agreed in writing with Panmure
Gordon, represents and warrants that neither it nor the beneficial
owner of such Placing Shares will be a resident of Restricted
Jurisdiction;
13. acknowledges that the Placing Shares have not been and will
not be registered under the securities legislation of Restricted
Jurisdiction and, subject to certain exceptions, may not be
offered, sold, taken up, renounced or delivered or transferred,
directly or indirectly, within those jurisdictions;
14. represents and warrants that the issue to it, or the person
specified by it for registration as holder, of Placing Shares will
not give rise to a liability 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
transfer Placing Shares into a clearance system;
15. represents and warrants that: (i) it has complied with and
will continue to comply with its obligations under the Market Abuse
Regulation (EU) No. 596/2014 as it forms part of the law of England
and Wales by virtue of the European Union (Withdrawal) Act 2018
("EUWA"), Criminal Justice Act 1993 and Part VIII of the Financial
Services and Markets Act 2000, as amended ("FSMA") and other
applicable law; (ii) in connection with money laundering and
terrorist financing, it has complied with its obligations under the
Proceeds of Crime Act 2002 (as amended), the Terrorism Act 2000 (as
amended), the Terrorism Act 2006, the Money Laundering, Terrorist
Financing and Transfer of Funds (Information on the Payer) 2017
Regulations, and any other applicable law (where all such
legislation listed under this (ii) shall together be referred to as
the "AML Legislation"); and (iii) it is not a person: (1) with whom
transactions are prohibited under the Foreign Corrupt Practices Act
of 1977 or any economic sanction programmes administered by, or
regulations promulgated by, the Office of Foreign Assets Control of
the U.S. Department of the Treasury; (2) named on the Consolidated
List of Financial Sanctions Targets maintained by HM Treasury of
the United Kingdom; or (3) subject to financial sanctions imposed
pursuant to a regulation of the EU or a regulation adopted by the
United Nations (together, the "Regulations"); 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 and pursuant to AML
Legislation and has obtained all governmental and other consents
(if any) which may be required for the purpose of, or as a
consequence of, such purchase, and it will provide promptly to
Panmure Gordon or the Company such evidence, if any, as to the
identity or location or legal status of any person (including in
relation to the beneficial ownership of any underlying investor)
which Panmure Gordon or the Company may request from it in
connection with the Placing (for the purpose of complying with such
Regulations or ascertaining the nationality of any person or the
jurisdiction(s) to which any person is subject or otherwise or any
other information as may be required to comply with legal or
regulatory requirements (including in particular under the AML
Legislation)) in the form and manner requested by Panmure Gordon or
the Company on the basis that any failure by it to do so may result
in the number of Placing Shares that are to be purchased by it or
at its direction pursuant to the Placing being reduced to such
number, or to nil, as Panmure Gordon may decide at its sole
discretion;
16. if a financial intermediary, as that term is used in Article
5(1) of the UK Prospectus Regulation, represents and warrants that
the Placing Shares purchased 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
Member State of the EEA or the UK other than EU Qualified Investors
or UK Qualified Investors respectively, or in circumstances in
which the prior consent of Panmure Gordon has been given to the
offer or resale;
17. represents and warrants that it has not offered or sold and
will not offer or sell any Placing Shares to persons in the EEA or
the UK prior to Admission 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 in and which will not result in an offer to the public in
any Member State of the EEA or the UK within the meaning of the EU
Prospectus Regulation or UK Prospectus Regulation respectively;
18. represents and warrants that 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 the FSMA) relating to
the Placing Shares in circumstances in which section 21(1) of the
FSMA does not require approval of the communication by an
authorised person;
19. represents and warrants that it has complied and will comply
with all applicable provisions of the FSMA and the Financial
Services Act 2012 with respect to anything done by it in relation
to the Placing Shares in, from or otherwise involving, the United
Kingdom;
20. if in the United Kingdom, represents and warrants that it is
a UK Qualified Investor who: (i) falls with Articles 49(2)(A) to
(D) or 19(5) of the Order or (ii) it is a person to whom the
Placing Shares may otherwise be lawfully offered under such Order
or, if it is receiving the offer in circumstances under which the
laws or regulations of a jurisdiction other than the United Kingdom
would apply, it is a person to whom the Placing Shares may be
lawfully offered under that other jurisdiction's laws and
regulations; and (iii) is a "professional client" or an "eligible
counterparty" within the meaning of Chapter 3 of the FCA's Conduct
of Business Sourcebook;
21. represents and warrants that it and any person acting on its
behalf is entitled to acquire the Placing Shares under the laws of
all relevant jurisdictions and that it has all necessary capacity
and has obtained all necessary consents and authorities and taken
any other necessary actions 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 (including this Appendix)) and will honour such
obligations;
22. where it is acquiring Placing Shares for one or more managed
accounts, represents and warrants that it is authorised in writing
by each managed account: (i) to acquire the Placing Shares for each
managed account; (ii) to make on its behalf the representations,
warranties, acknowledgements, undertakings and agreements in this
Appendix and the Announcement of which it forms part; and (iii) to
receive on its behalf any investment letter relating to the Placing
in the form provided to it by Panmure Gordon;
23. undertakes that it (and any person acting on its behalf)
will make payment for the Placing Shares allocated to it in
accordance with this announcement (including this Appendix) on the
due time and date set out herein, failing which the relevant
Placing Shares may be placed with other subscribers or sold as
Panmure Gordon may in its sole discretion determine and without
liability to such Placee and it will remain liable and will
indemnify Panmure Gordon on demand for any shortfall below the net
proceeds of such sale and the placing proceeds of such Placing
Shares and may be required to bear the liability for any stamp duty
or stamp duty reserve tax or security transfer tax (together with
any interest or penalties due pursuant to or referred to in these
terms and conditions) which may arise upon the placing or sale of
such Placee's Placing Shares on its behalf;
24. acknowledges that neither Panmure Gordon, nor any of its
affiliates, or any person acting on behalf of any 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 and that participation in the Placing is on the
basis that it is not and will not be treated for these purposes as
a client of Panmure Gordon and that Panmure Gordon does not have
any duties or responsibilities to it for providing the protections
afforded to their respective 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 their rights and obligations thereunder,
including any rights to waive or vary any conditions or exercise
any termination right;
25. undertakes that the person whom it specifies for
registration as holder of the Placing Shares will be (i) itself; or
(ii) its nominee, as the case may be. Neither Panmure Gordon nor
the Company will be responsible for any liability to stamp duty or
stamp duty reserve tax resulting from a failure to observe this
requirement. Each Placee and any person acting on behalf of such
Placee agrees to participate in the Placing and it agrees to
indemnify the Company and Panmure Gordon in respect of the same on
the basis that the Placing Shares will be issued to the CREST stock
account of Panmure Gordon who will hold them as nominee on behalf
of such Placee until settlement in accordance with its standing
settlement instructions;
26. acknowledges that these terms and conditions and any
agreements entered into by it pursuant to these terms and
conditions and any non-contractual obligations arising out of or in
connection with such agreement 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 (including non-contractual matters)
arising out of any 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 the Company or Panmure Gordon 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;
27. acknowledges that time shall be of the essence as regards to
obligations pursuant to this Appendix;
28. agrees that the Company, Panmure Gordon and their respective
affiliates and others will rely upon the truth and accuracy of the
foregoing representations, warranties, acknowledgements and
undertakings which are given to Panmure Gordon on its own behalf
and on behalf of the Company and are irrevocable and are
irrevocably authorised to produce this announcement or a copy
thereof to any interested party in any administrative or legal
proceeding or official inquiry with respect to the matters covered
hereby;
29. agrees to indemnify on an after-tax basis and hold the
Company, Panmure Gordon and its respective affiliates 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 in this Appendix and further agrees
that the provisions of this Appendix shall survive after completion
of the Placing;
30. acknowledges that no action has been or will be taken by any
of the Company, Panmure Gordon or any person acting on behalf of
the Company or Panmure Gordon that would, or is intended to, permit
a public offer of the Placing Shares in any country or jurisdiction
where any such action for that purpose is required;
31. acknowledges that it is an institution that has knowledge
and experience in financial, business and international investment
matters as is required to evaluate the merits and risks of
subscribing for the Placing Shares. It further acknowledges that it
is experienced in investing in securities of this nature and in
this sector and is aware that it may be required to bear, and it,
and any accounts for which it may be acting, are able to bear, the
economic risk of, and is able to sustain, a complete loss in
connection with the Placing. It has relied upon its own examination
and due diligence of the Company and its associates taken as a
whole, and the terms of the Placing, including the merits and risks
involved;
32. acknowledges that its commitment to subscribe for Placing
Shares on the terms set out herein will continue, notwithstanding
any amendment that may in the future be made to the terms of the
Placing and that Placees will have no right to be consulted or
require that their consent be obtained with respect to the
Company's conduct of the Placing;
33. acknowledges that Panmure Gordon or any of its affiliates
acting as an investor for its own account may take up shares in the
Company and in that capacity may retain, purchase or sell for its
own account such shares and may offer or sell such shares other
than in connection with the Placing;
34. represents and warrants that, if it is a pension fund or
investment company, its purchase of Placing Shares is in full
compliance with all applicable laws and regulation; and
35. to the fullest extent permitted by law, it acknowledges and
agrees to the disclaimers contained in the announcement, including
this Appendix.
The representations, warranties, acknowledgments and
undertakings contained in this Appendix are given to Panmure Gordon
and the Company and are irrevocable and shall not be capable of
termination in any circumstances.
The agreement to settle a Placee's subscription (and/or the
subscription of a person for whom such Placee is contracting as
agent) free of stamp duty and stamp duty reserve tax depends on the
settlement relating only to a subscription by it and/or such person
direct from the Company for the Placing Shares in question. Such
agreement assumes that the Placing Shares are not being subscribed
for in connection with arrangements to issue depositary receipts or
to transfer the Placing Shares into a clearance service. If there
are any such arrangements, or the settlement relates to any other
subsequent dealing in the Placing Shares, stamp duty or stamp duty
reserve tax may be payable, for which neither the Company nor
Panmure Gordon will be responsible, and the Placee to whom (or on
behalf of whom, or in respect of the person for whom it is
participating in the Placing as an agent or nominee) the
allocation, issue or delivery of Placing Shares has given rise to
such UK stamp duty or stamp duty reserve tax undertakes to pay such
UK stamp duty or stamp duty reserve tax forthwith and to indemnify
on an after-tax basis and to hold harmless the Company and Panmure
Gordon in the event that any of the Company and/or Panmure Gordon
has incurred any such liability to UK stamp duty or stamp duty
reserve tax. If this is the case, each Placee should seek its own
advice and notify Panmure Gordon accordingly.
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 outside the
UK by them or any other person on the subscription by them of any
Placing Shares or the agreement by them to subscribe for any
Placing Shares.
Each Placee, and any person acting on behalf of the Placee,
acknowledges that Panmure Gordon 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.
Each Placee and any person acting on behalf of the Placee
acknowledges and agrees that Panmure Gordon or any of its
affiliates may, at their absolute discretion, agree to become a
Placee in respect of some or all of the Placing Shares.
When a Placee or person acting on behalf of the Placee is
dealing with Panmure Gordon, any money held in an account with
Panmure Gordon 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 rules and regulations of the FCA made under the
FSMA. The 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 Panmure
Gordon's money in accordance with the client money rules and will
be used by Panmure Gordon in the course of its own business and the
Placee will rank only as a general creditor of Panmure Gordon.
All times and dates in this announcement (including this
Appendix) may be subject to amendment, and Placees' commitments,
representations and warranties are not conditional on any of the
expected times and dates in this announcement (including this
Appendix) being achieved. Panmure Gordon shall notify the Placees
and any person acting on behalf of the Placees of any changes.
Past performance is no guide to future performance and persons
needing advice should consult an appropriately qualified
independent financial adviser.
Panmure Gordon is entitled, at its discretion and out of its own
resources, at any time to rebate to some or all of its investors,
or to other parties, part or all of its fees relating to the
Placing.
MISCELLANEOUS
Solely for the purposes of the product governance requirements
contained within: (a) EU Directive 2014/65/EU on markets in
financial instruments, as amended ("MiFID II"); (b) Articles 9 and
10 of Commission Delegated Directive (EU) 2017/593 supplementing
MiFID II; and (c) local implementing measures, each as they form
part of the law of England and Wales by virtue of EUWA (together,
the "Product Governance Requirements"), and disclaiming all and any
liability, whether arising in tort, contract or otherwise, which
any "manufacturer" (for the purposes of the Product Governance
Requirements) 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
as defined in MiFID II; and (ii) eligible for distribution through
all distribution channels as are permitted by MiFID II (the "Target
Market Assessment"). Notwithstanding the Target Market Assessment,
Placees 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, Panmure Gordon will only procure
investors who meet the criteria of professional clients and
eligible counterparties. For the avoidance of doubt, the Target
Market Assessment does not constitute: (a) an assessment of
suitability or appropriateness for the purposes of MiFID II; or (b)
a recommendation to any investor or group of investors to invest
in, or purchase, or take any other action whatsoever with respect
to the Placing Shares.
Each distributor is responsible for undertaking its own target
market assessment in respect of the Placing Shares and determining
appropriate distribution channels.
The content of this announcement has been prepared by, and is
the sole responsibility of, Diurnal Group plc.
The information contained in this announcement is given at the
date of its publication (unless otherwise marked) and is subject to
updating, revision and amendment from time to time. Neither the
content of the Company's website nor any website accessible by
hyperlinks to the Company's website is incorporated in, or forms
part of, this announcement.
Certain statements in this announcement are forward-looking
statements which are based on the Company's expectations,
intentions and projections regarding its future performance,
anticipated events or trends and other matters that are not
historical facts. These forward-looking statements, which may use
words such as "aim", "anticipate", "believe", "could", "intend",
"estimate", "expect" and words of similar meaning, include all
matters that are not historical facts. These forward-looking
statements involve risks, assumptions and uncertainties that could
cause the actual results of operations, financial condition,
liquidity and dividend policy and the development of the industries
in which the Company's businesses operate to differ materially from
the impression created by the forward-looking statements. These
statements are not guarantees of future performance and are subject
to known and unknown risks, uncertainties and other factors that
could cause actual results to differ materially from those
expressed or implied by such forward-looking statements. Given
those risks and uncertainties, prospective investors are cautioned
not to place undue reliance on forward-looking statements.
Forward-looking statements speak only as of the date of such
statements and, except as required by the FCA, the London Stock
Exchange or applicable law, the Company undertakes no obligation to
update or revise publicly any forward-looking statements, whether
as a result of new information, future events or otherwise.
Panmure Gordon (UK) Limited ("Panmure Gordon"), which is
authorised and regulated in the United Kingdom by the FCA, is
acting as nominated adviser and broker to the Company in connection
with the Placing and Admission and to no-one else and will not be
responsible to anyone other than the Company for providing the
protections afforded to its clients, nor for providing advice in
relation to the Placing or Admission or any other matter referred
to in this Announcement. Panmure Gordon's responsibilities as the
Company's nominated adviser under the AIM Rules for Nominated
Advisers are owed solely to London Stock Exchange plc and are not
owed to the Company or to any director of the Company or to any
other person in respect of any decision to acquire shares in the
Company in reliance on any part of this announcement.
Neither Panmure Gordon or any of its directors, officers,
employees, advisers, affiliates or agents, accepts any
responsibility or liability whatsoever for or makes any
representation or warranty, express or implied, as to this
announcement, including the truth, accuracy or completeness of the
information in this announcement (or whether any information has
been omitted from the announcement) or for any loss howsoever
arising from any use of the announcement or its contents. Panmure
Gordon and its directors, officers, employees, advisers, affiliates
or agents, accordingly disclaim all and any liability whether
arising in tort, contract or otherwise which they might otherwise
have in respect of this announcement or its contents or otherwise
arising in connection therewith.
Data Protection
The processing of a Placee's personal data by the Company will
be carried out in compliance with the applicable data protection
legislation and with its Privacy Notice, a copy of which can be
found on the Company's website
https://www.diurnal.co.uk/privacy-policy/ .
Each Placee acknowledges that it has read and understood the
processing activities carried out by the Company as informed in the
referred Privacy Notice.
APPIX III
DEFINITIONS
The following definitions apply throughout the Announcement,
unless the context requires otherwise:
"Admission" admission of the New Ordinary Shares
to trading on AIM becoming effective
in accordance with the AIM Rules
"AIM" AIM, the market of that name operated
by London Stock Exchange
"AIM Rules" the AIM Rules for Companies as published
by the London Stock Exchange from time
to time
"Board" or "Directors" the directors of the Company as at
the date of the Circular
"Capital Raising" the Placing, the Subscription and the
Open Offer, taken together
"certificated" or "in in relation to a share or other security,
certificated form" not in uncertificated form (that is,
not in CREST)
"Company" or "Diurnal" Diurnal Group plc, a public limited
company incorporated in England and
Wales with registered number 09846650
"CREST" the relevant system (as defined in
the CREST Regulations) in respect of
which Euroclear is the operator (as
defined in the CREST Regulations),
which facilitates the transfer of title
to shares in uncertificated form
"CREST Regulations" the Uncertificated Securities Regulations
2001 (SI 2001/3755) (as amended)
"EU" the European Union
"Euroclear" Euroclear UK & Ireland Limited
"Excess Application Facility" the arrangement pursuant to which Qualifying
Shareholders may apply for additional
Open Offer Shares in excess of their
Open Offer Entitlement in accordance
with the terms and conditions of the
Open Offer
"Excess CREST Open Offer in respect of each Qualifying CREST
Entitlements" Holder who has taken up their Open
Offer Entitlement in full, the Excess
Open Offer Entitlements credited to
his stock account in CREST
"Excess Open Offer Entitlements" in respect of each Qualifying Shareholder,
the entitlement (in addition to his
Open Offer Entitlement) to apply for
Open Offer Shares pursuant to the Excess
Application Facility, subject to the
terms and conditions of the Open Offer
"Excess Shares" Open Offer Shares in addition to the
Open Offer Entitlement for which Qualifying
Shareholders may apply under the Excess
Application Facility
"Ex-entitlement Date" the date on which the Existing Ordinary
Shares are marked "ex" for entitlement
under the Open Offer, being 8.00 a.m.
on 22 April 2021
"Existing Ordinary Shares" the 138,337,404 Ordinary Shares in
issue on the date of this announcement
"FCA" the Financial Conduct Authority
"Form of Proxy" a form of proxy for use in relation
to the General Meeting
"FSMA" Financial Services and Market Act 2000
(as amended)
"General Meeting" the general meeting of the Company,
convened for 10.00 a.m. on 10 May 2021
or any adjournment thereof, notice
of which will be set out at the end
of the Circular
"Group" the Company and its subsidiaries
"HMRC" Her Majesty's Revenue and Customs
"ISIN" International Securities Identification
Number
"London Stock Exchange" London Stock Exchange plc
"New Ordinary Shares" the Placing Shares, the Subscription
Shares and the Open Offer Shares
"Notice of General Meeting" the notice convening the General Meeting
"Open Offer" the conditional invitation made to
Qualifying Shareholders to apply to
subscribe for the Open Offer Shares
at the Issue Price on the terms and
subject to the conditions set out in
the Circular and (if relevant) in the
Application Form
"Open Offer Entitlement" in respect of each Qualifying Shareholder,
the entitlement to apply for the number
of Open Offer Shares pro rata to their
holding of Existing Ordinary Shares
pursuant to the Open Offer as described
in the Circular
"Open Offer Shares" the 2,852,317 new Ordinary Shares being
made available to Qualifying Shareholders
pursuant to the Open Offer
"Ordinary Shares" ordinary shares of GBP0.05 each in
the capital of the Company
"Panmure Gordon" Panmure Gordon (UK) Limited
"Placing and Open Offer the agreement dated 21 April 2021 between
Agreement" the Company and Panmure Gordon in respect
of the Placing, Subscription and Open
"Placees" Offer
the persons who have agreed to subscribe
for Placing Shares under the Placing
"Placing" the conditional placing by the Company
of the Placing Shares with the Placees,
otherwise than on a pre-emptive basis,
at the Issue Price pursuant to the
Placing and Open Offer Agreement
"Issue Price" 70 pence per New Ordinary Share
"Placing Shares" the new Ordinary Shares which are the
subject of the Placing
"Registrar" Link Market Services Limited
"Regulatory Information has the meaning given in the AIM Rules
Service"
"Restricted Jurisdiction" the US, Canada, Australia, New Zealand,
the Republic of South Africa or Japan
"Resolutions" the resolutions to be proposed at the
General Meeting as set out in the Notice
of General Meeting
"Securities Act" US Securities Act of 1933 (as amended)
"Shareholders" the holders of Existing Ordinary Shares
"Subscription" the direct subscription with the Company
for the Subscription Shares at the
Issue Price by certain Directors pursuant
to the Subscription Letters
"Subscription Letters" the subscription letters entered into
between the Company and certain Directors
pursuant to which such Directors have
agreed to subscribe for the Subscription
Shares
"Subscription Shares" the 64,285 New Ordinary Shares which
are subject of the Subscription
"stock account" an account within a member account
in CREST to which a holding of a particular
share or other security in CREST is
credited
"uncertificated" or "in in relation to a share or other security,
uncertificated form" recorded on the relevant register as
being held in uncertificated form in
CREST and title to which, by virtue
of the CREST Regulations, may be transferred
through CREST
"United Kingdom" or "UK" the United Kingdom of Great Britain
and Northern Ireland
"United States", "United the United States of America, its territories
States of America" or and possessions, any state of the United
"US" States of America and the District
of Columbia and all areas subject to
its jurisdiction
APPIX IV
GLOSSARY OF TECHNICAL AND SCIENTIFIC TERMS
The following technical and scientific terms apply throughout
the Announcement, unless the context requires otherwise:
Adrenal glands the adrenal glands are small glands
that sit on top of the kidneys in the
retroperitoneum (that is, the deepest
part of the abdomen). The adrenal glands
have two layers: the cortex and the
medulla. The cortex is located on the
outer layer of the adrenal gland and
secretes a number of different hormones,
including cortisol, aldosterone and
androgens. Diseases of the adrenal
cortex may be caused by either too
much or too little of any of the above
hormones;
Adrenal Franchise the Group's hydrocortisone product
"franchise" or range designed to treat
patients with diseases of cortisol
deficiency;
Adrenal Insufficiency a condition characterised by deficiency
or AI in cortisol, an essential hormone in
regulating metabolism and the response
to stress. Poor control of disease
can result in precocious puberty in
young children, virilisation in girls
and chronic fatigue leading to a poor
quality of life in adulthood resulting
in increased morbidity and mortality;
androgens hormones that regulate the development
and maintenance of male characteristics;
CHMP the Committee for Medicinal Products
for Human Use;
Congenital Adrenal Hyperplasia a condition caused by deficiency of
or CAH adrenal enzymes, most commonly 21-hydroxylase.
This enzyme is required to produce
cortisol. The block in the cortisol
production pathway causes the over-production
of androgens, which are precursors
to cortisol. The condition is congenital
(inherited at birth) and affects both
sexes. The cortisol deficiency and
over-production of male sex hormones
can lead to increased mortality, infertility
and severe development defects including
ambiguous genitalia, premature (precocious)
sexual development and short stature.
Sufferers, even if treated, remain
at risk of death through an adrenal
crisis;
Cortisol a life-sustaining adrenal hormone essential
to the maintenance of homeostasis.
Called the "stress hormone", cortisol
influences, regulates or modulates
many of the changes that occur in the
body in response to stress, including
(but not limited to): blood sugar (glucose)
levels; fat, protein and carbohydrate
metabolism to maintain blood glucose
(gluconeogenesis); immune responses;
anti-inflammatory actions; blood pressure;
heart and blood vessel tone and contraction;
and central nervous system activation.
Cortisol levels have a rhythm around
the day and night, a circadian rhythm.
Cortisol levels are high on waking
(between 7.00 a.m. and 10.00 a.m.),
gradually decline over the day with
low levels on going to sleep (between
midnight and 2.00 a.m.) and then building-up
overnight to peak again shortly after
waking;
EMA the European Medicine Agency;
FDA the US Food and Drug Administration;
Homeostasis the tendency towards a relatively stable
equilibrium between inter-dependent
elements in the human body, as maintained
by physiological processes;
Hypogonadism diminished functional activity of the
gonads (the testes);
Hypothyroidism also called underactive thyroid or
low thyroid, is a disorder of the endocrine
system in which the thyroid gland does
not produce enough thyroid hormone,
causing a number of symptoms, including
poor ability to tolerate cold, a feeling
of tiredness, constipation, depression
and weight gain;
Investigative New Drug a request for FDA authorisation to
Application or IND administer an investigational drug
to humans in the US. Such authorisation
Marketing Authorisation must be secured prior to interstate
Application or MAA shipment and administration of any
new drug that is not the subject of
an approved new drug application;
a Marketing Authorisation Application
made seeking authorisation of a new
medicine. Once granted by the European
Commission, the centralised marketing
authorisation is valid in all EU Member
States, Iceland, Norway and Liechtenstein;
New Drug Application the FDA's New Drug Application is the
or NDA vehicle in the United States through
which drug sponsors formally propose
that the FDA approve a new pharmaceutical
for sale and marketing;
Orphan Drug Designation in the European Union, orphan drug
designation under Regulation (EC) No.
141/2000 by the EMA's Committee for
Orphan Medicinal Products and, in the
United States, orphan drug designation
under the Orphan Drug Act of 1983;
Orphan Drug Status exclusivity for an orphan drug that
is confirmed by a relevant regulatory
authority in connection with an Orphan
Drug Designation
Phase I clinical trial a clinical trial which aims to test
the safety of a new medicine/treatment
on humans for the first time. A small
number of people, who may be healthy
volunteers, are given the medicine/treatment.
Researchers test for side effects and
calculate what the right dose might
be to use in treatment (known as dose-ranging
studies);
Phase II clinical trial a second phase of clinical trial which
tests a new medicine/treatment on a
group of people, usually a small number
of patients, in order to gain a better
understanding of its effects in the
short term. A Phase II clinical trial
may also be conducted on a blind, double-blind
and/or randomised basis;
Phase III clinical trial a third phase clinical trial only for
medicines/treatments that have already
passed a Phase I clinical trial and
a Phase II clinical trial. In a Phase
III clinical trial, a medicine/treatment
is tested on a further increased number
of people (sometimes several thousand)
who are ill and compared against an
existing treatment or placebo to see
if it is better in practice and if
it has important side effects. Most
Phase III clinical trials are also
conducted on a blind, double-blind
and/or randomised basis;
PUMA a Paediatric Use Marketing Authorisation
that provides incentives for products
intended to be used in children in
Europe. A product that benefits from
a PUMA will have a total of 10 years
exclusivity (eight years of data exclusivity
and an additional 2 years of market
exclusivity) with effect from market
approval in Europe; and
T3 the thyroid hormone triiodothyronine,
produced by the thyroid gland.
APPENDIX V
EXPECTED TIMETABLE OF PRINCIPAL EVENTS
Record date for entitlement under the Close of business on 20
Open Offer April 2021
Announcement of the Placing, Subscription 21 April 2021
and Open Offer
Publication and posting of the Circular by 22 April 2021
and the Application Form
Ex-entitlement Date 8:00 a.m. on 22 April 2021
Open Offer Basic and Excess Entitlements 23 April 2021
credited to CREST Stock Accounts of Qualifying
CREST Holders
Recommended last time and date for requesting 4:30 p.m. on 30 April 2021
withdrawal of Open Offer Entitlements
from CREST for Qualifying CREST Holders
Latest time and date for depositing Open 3:00 p.m. on 4 May 2021
Offer Entitlements into CREST
Latest time and date for splitting Application 3:00 p.m. on 5 May 2021
Forms
(to satisfy bona fide market claims only)
Latest time and date for receipt of electronic 10:00 a.m. on 6 May 2021
proxy appointments via the CREST system
and, to the extent one is requested, a
hard copy Form of Proxy, to be valid at
the General Meeting
Latest time and date for acceptance of 11:00 a.m. on 7 May 2021
the
Open Offer and receipt of completed Application
Forms
General Meeting 10:00 a.m. on 10 May 2021
Announcement of result of Open Offer and 10 May 2021
result of General Meeting
Admission and commencement of dealings 8:00 a.m. on 11 May 2021
in the New Ordinary Shares
New Ordinary Shares credited to CREST 11 May 2021
members' account in uncertificated form
Despatch of definitive share certificates Within 5 days of Admission
for New Ordinary Shares in certificated
form
Notes
(1) References to are to London time (unless otherwise stated).
(2) The dates and timing of the events in the above timetable
and in the rest of the Circular are indicative only and may be
subject to change.
(3) If any of the above times or dates should change, the
revised times and/or dates will be notified by an announcement
through a Regulatory Information Service.
[1] Market sizes are based on Company estimates
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END
IOEDKKBBDBKBCQB
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