Diurnal Group PLC Operational Update (6414J)
15 April 2020 - 4:00PM
UK Regulatory
TIDMDNL
RNS Number : 6414J
Diurnal Group PLC
15 April 2020
15 April 2020
Diurnal Group plc
("Diurnal" or the "Company")
Operational Update
Arrangements in place to ensure constant drug supply to patients
across Europe
Steps taken to minimise impact of COVID-19 on business
operations
Strong cash position following receipt of Eton Pharmaceuticals
payment, with the Company now financed to profitability
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, today provides a business update in relation to clinical,
regulatory and commercial operations in the context of the current
global coronavirus (COVID-19) outbreak.
Diurnal's priorities are ensuring the health and safety of its
staff and that of patients enrolled in the Company's ongoing
clinical study and ensuring that patients have uninterrupted access
to its approved drug, Alkindi(R) (hydrocortisone granules in
capsules for opening). To this end, Diurnal is focused on
minimising any disruption to its business operations and ensuring
that it is adequately capitalised to execute upon its business plan
for the foreseeable future, specifically:
-- Staff safety and operational continuity - The Company's small
number of office-based staff are now working remotely, and
contingency plans have been established to support business
continuity.
-- Clinical study participation - Participating centres in
Diurnal's currently ongoing clinical trial, the DIUR-006
Chronocort(R) (modified release hydrocortisone) European safety
extension study, have arranged for remote monitoring of subjects
and plans are in place to ensure that patients have access to the
drug. No subjects have been required to leave the DIUR-006 study to
date as a result of restrictions imposed by virtue of the COVID-19
outbreak.
-- Drug supply - To mitigate the impact of potential closure of
state borders and protect patients from any consequential reduction
in supply of Alkindi(R) , the Company has ensured that enough drug
stock is available to meet foreseeable demand across all key
European territories. Alkindi(R) revenues in Europe continue to
track in line with the Board's expectations.
-- Regulatory process - To date, the Company has not experienced
any material delays to the regulatory processes for Chronocort(R)
in Europe and Alkindi(R) Sprinkle in the US. Diurnal will continue
to work with the European Medicines Agency (EMA) and US Food &
Drug Administration (FDA), respectively, during the review
processes and remains confident in the regulatory pathway timelines
previously provided.
-- Financial position - Following the announcement of its deal
with Eton Pharmaceuticals for the exclusive licensing rights for
Alkindi(R) Sprinkle in the US on 27 March 2020, the Company has now
received the initial non-refundable upfront payment of $3.5
million. Combined with the result of the Group's recent GBP11.2
million placing in March 2020, the Board believe that the Company
has enough cash to take it through to profitability based upon
current plans and assumptions, including expectations regarding the
timing of product approvals and sales projections.
As a consequence of these steps, the Board is confident that
Diurnal is well-positioned to minimise the impact of COVID-19 on
the Company's business. The Company will continue to monitor the
COVID-19 situation closely and keep the market updated with any
material future developments as appropriate.
Martin Whitaker, CEO of Diurnal, commented:
"Whilst the effects of COVID-19 continue to be felt throughout
the world, our main priority is to closely monitor the situation
for all our employees and patients. We will continue to move our
business forward where possible. We have put in place contingency
plans for the continued roll-out of Alkindi(R) in Europe and
support of patients in the ongoing Chronocort(R) study and will
monitor the effectiveness of these over the coming months. The
Board remains confident that the Company is in a strong position
both financially and operationally, now with enough cash to take
the business through to profitability based upon its current plans
without having to return to the market."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
For further information, please visit www.diurnal.co.uk or
contact:
+44 (0)20 3727
Diurnal Group plc 1000
Martin Whitaker, Chief Executive Officer
Richard Bungay, Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser +44 (0)20 7886
and Joint Broker) 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns
+44 (0)20 7894
Cantor Fitzgerald Europe (Joint Broker) 7000
Corporate Finance: Phil Davies, Will Goode,
Luke Philippou
Healthcare Equity Sales: Andrew Keith
+44 (0)20 3727
FTI Consulting (Media and Investor Relations) 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Diurnal Group plc
Founded in 2004, Diurnal is a UK-headquartered, European
specialty pharma company developing pharmaceutical products for the
global market for the life-long treatment of chronic endocrine
conditions, including congenital adrenal hyperplasia and adrenal
insufficiency. 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: April 2020 Code: CORP-GB-0055
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END
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