DNL.L Regulatory News (DNL)

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® (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® (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®, the Company has ensured that enough drug stock is available to meet foreseeable demand across all key European territories. Alkindi® 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® in Europe and Alkindi® 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® 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 £11.2 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® in Europe and support of patients in the ongoing Chronocort® 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).

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