Our Latest News

07Oct2022

AWMSG recommends Efmody® as treatment option for adolescents and adults with congenital adrenal hyperplasia in Wales

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the All Wales Medicines Strategy Group (AWMSG) has recommended Efmody ® (hydrocortisone modified-release hard capsules) as an option for restricted use to treat adolescents and adults with congenital adrenal hyperplasia (CAH) within NHS Wales. The AWMSG’s recommendation means that Efmody® is available for use as a second-line treatment option in adolescents with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone; and as a third-line treatment in adults with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone and/or prednisolone. Diurnal will commercially roll-out Efmody® in Wales using its existing sales and marketing infrastructure and supply chain. Efmody® has been available for the treatment of CAH in the UK since launch in October 2021. Efmody® is licensed for the treatment of congenital adrenal hyperplasia in adolescents aged 12 years and older and in adults in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA). Richard Bungay, Interim Chief Executive Officer of Diurnal commented: "We are delighted that, after a rigorous review, the AWMSG has recognised the potential for Efmody® to address important unmet needs in patients suffering with CAH. Diurnal believes the use of this medicine will improve the lives of adults and adolescents in Wales living with this rare disease.” For further information, please visit  null  or contact: Diurnal Group plc  +44 (0)20 3727 1000 Richard Bungay, Interim Chief Executive Officer Panmure Gordon (UK) Limited (Nominated Adviser and Corporate Broker)  +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations)  +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis 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  null About congenital adrenal hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (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 issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroid) preparations including hydrocortisone, dexamethasone and prednisolone, with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe. About Efmody® (hydrocortisone modified-release hard capsules) Efmody® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The MHRA and European Commission marketing authorisation approval of Efmody ® was based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, including sites in Great Britain, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody ® over an extended period, with a number of patients on this trial having been treated for over 5 years. Summary of Product Characteristics (SmPC) for UK including Northern Ireland) can be found  null . Date of Preparation: October 2022 Code: CH EU-GLO-0011

14Sep2022

Interim Results for the Twelve Months Ended 30 June 2022

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its results for the twelve months ended 30 June 2022 (the “Period”) and following the publication of a trading update on 26 July 2022. Operational highlights (including post-period): ●  Proposed acquisition by Neurocrine Biosciences, Inc. (“Neurocrine”) o On 30 August 2022, Diurnal announced the terms of a recommended cash acquisition pursuant to which Neurocrine intends to acquire the entire issued and to be issued ordinary share capital of Diurnal o The acquisition is currently expected to complete during late October or early November 2022, subject to satisfaction or (where applicable) waiver of the conditions to the acquisition ●  Commercial products o  Alkindi®  (hydrocortisone granules in capsules for opening) ▪ Alkindi® approved in Switzerland by SwissMedic ▪ US partner Eton Pharmaceuticals announced co-promotion for Alkindi Sprinkle® in US with Tolmar Pharmaceuticals ▪ Distribution agreement with Vector Pharma for named patient sales of Alkindi® covering Middle East and North Africa o  Efmody®  (hydrocortisone modified-release hard capsules) ▪ Initial commercial launches in Germany, UK, Austria and the Netherlands ▪ Reimbursement approval in Norway ▪ Post-Period end, agreed reimbursement in Italy, with launch planned for September 2022 ▪ Company to generate further clinical and health-economic data to support a re-submission to the Scottish Medicines Consortium (SMC) at the earliest possible opportunity following announcement that Efmody® was not recommended for automatic reimbursement within NHS Scotland ▪ Extension of existing Alkindi® distribution and marketing agreement with EffRx for Alkindi® in Switzerland to cover Efmody ® o Expansion of global footprint for Alkindi® and Efmody ® through a new distribution agreement with ExCEEd Orphan for Central Eastern European (CEE) countries and an extension of the existing distribution agreement with Er-Kim covering Greece, Cyprus and Malta ●  Development products o  DNL-0200  (hydrocortisone modified-release hard capsules – previously referred to as Chronocort®, commercialised as Efmody® in Europe) ▪ Agreement of Special Protocol Assessment (SPA) for DNL-0200 US Phase 3 study (CONnECT) in congenital adrenal hyperplasia (CAH) with the US Food and Drug Administration (FDA) ▪ Agreement with Japanese Pharmaceuticals and Medical Devices Agency (PMDA) that CONnECT study can act as the registration study for DNL-0200 in Japan ▪ First patients dosed in the CONnECT study with headline data expected in 2024 ▪ First patient dosed in the CHAMPAIN study (European Phase 2 trial of DNL-0200 in adrenal insufficiency (AI)), with headline data now expected in Q1 2023 o  DNL-0300  (native oral testosterone formulation – previously referred to as DITEST™) ▪ Submission of Investigational New Drug (IND) application and subsequent feedback received from the FDA enabling finalisation of protocol for multiple ascending dose (MAD) Phase I study Financial highlights ● Product sales (including royalties) for the Period increased to £4.62m, representing year-on-year growth of 104% (twelve months ended 30 June 2021: £2.27m) o Alkindi® product sales (including royalties) for the Period increased to £3.65m, representing year-on-year growth of 61% (twelve months ended 30 June 2021: £2.27m) o Efmody® initial product sales for the Period of £0.97m (twelve months ended 30 June 2021: £nil) o Total revenues for the Period of £4.68m, reflecting licensing income of £0.06m (twelve months ended 30 June 2021: total revenues of £4.37m, reflecting licensing income of £2.10m) ● Operating loss for the Period of £18.96m (twelve months ended 30 June 2021: £11.60m), reflecting increased investment in the product pipeline and the commercial roll-out of Efmody® across Europe ● Cash and cash equivalents at 30 June 2022: £16.49m (30 June 2021: £34.04m) ● As a result of the slower Efmody® sales growth expected following the SMC decision in March 2022, the Company has previously indicated that it will require further financing to reach profitability. Corporate highlights ● Appointment of Anders Härfstrand as Chairman and Jean-Michel Cosséry and Deborah Jorn as Non-Executive Directors in November 2021, each bringing significant commercial experience to the Board ● Appointment of Richard Bungay as Interim Chief Executive Officer following the departure of Martin Whitaker as Chief Executive Officer Richard Bungay, Interim Chief Executive Officer of Diurnal, commented: “Despite a number of challenges during the Period, we are pleased that Efmody® revenues are currently in line with our expectations in Germany, our first major launch market, and that Alkindi® growth has resumed following a reduction in pandemic-related restrictions.” “Our near-term focus is the commercial roll-out of Efmody® in those European territories where we have been able to secure reimbursement based on our current clinical data. In the longer-term, the Company will continue to drive the momentum of Alkindi®, and focus on the generation of new clinical data from the CHAMPAIN and CONnECT studies, which we believe will provide additional data to support continued Efmody® reimbursement discussions in Europe.” As previously reported, Diurnal’s financial year end has been changed to 31 December, with the next statutory reporting due for the 18-month period to 31 December 2022. In the Interim Results: ● “bn”, “m” and “k” represent billion, million and thousand, respectively ● “Group” is the Company and its subsidiary undertakings, Diurnal Limited and Diurnal Europe B.V. This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data is included to allow informed investment decisions. This announcement contains inside information for the purposes of the UK Market Abuse Regulation (UK MAR). For further information, please visit  null  or contact: Diurnal Group plc  +44 (0)20 3727 1000 Richard Bungay, Interim Chief Executive Officer Mike Scott, Interim Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Corporate Broker)  +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations)  +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis 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  null Forward looking statements Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the Company believe that the expectations reflected in these statements are reasonable but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward-looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods. View full document: null Date of Preparation: September 2022             Code: CORP-GLO-0041

26Jul2022

Trading Update

Revenues in line with current expectations; strong sales growth (+104%) driven by good Alkindi® performance and initial sales of Efmody® Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today provides an unaudited trading update for the twelve-month period ended 30 June 2022 (the “Period”). Revenue Product sales (including royalties) for the Period increased to £4.62m, representing year-on-year growth of 104% (twelve months ended 30 June 2021: £2.27m). null null null Cash null Future reporting null Richard Bungay, Interim Chief Executive Officer of Diurnal commented: "We are pleased to have delivered revenues in line with current expectations, reflecting both continued growth in Alkindi® as well as the initial roll out of Efmody®, primarily in Germany. We look forward to providing a detailed update to investors on operational progress at our results presentation and R&D day in September 2022.” For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Richard Bungay, Interim Chief Executive Officer Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker) +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea, William Palmer-Brown Corporate Broking: Nick Adams, Nick Harland FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis 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  null Date of Preparation: July 2022 Code: CORP-GLO-0040

07Jun2022

Diurnal to present research into the treatment of CAH at ENDO 2022

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, will be presenting research findings on the treatment and management of congenital adrenal hyperplasia (CAH) at this year’s American Endocrine Society meeting, ENDO 2022, which will be taking place between 11-14 June 2022 in Atlanta, USA. Over the four-day meeting, the following topics will be presented: null null CAH occurs when the production of cortisol from the adrenal gland is limited due to a genetic deficiency. CAH is associated with over-production of male sex hormones resulting in ambiguous genitalia at birth, precocious sexual development, infertility in men and women, and increased mortality through adrenal crisis. Around 450,000 people globally are estimated to be living with a CAH disorder yet there is no standard treatment. Instead, a variety of steroids are used but data shows around two thirds of people living with CAH still have problems with disease control  null . Richard Bungay, Interim Chief Executive Officer of Diurnal commented: "These presentations at ENDO follow our very well attended presentations at the European Congress of Endocrinology meeting in Europe last month. Diurnal is committed to supporting research into diseases of cortisol deficiency and developing solutions to support patients with these life-long disorders. The interest we have received from the world’s leading endocrinologists demonstrates the progress we are making in the treatment and management of diseases of cortisol deficiency.” For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Richard Bungay, Interim Chief Executive Officer Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker) +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea, William Palmer-Brown Corporate Broking: Nick Adams, Nick Harland FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Vane Percy & Roberts (Medical Communications) +44 (0) 173 782 1890 Simon Vane Percy 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  null Date of Preparation: June 2022 Code: CORP-GLO-0039 null Mallappa, A., Merke, D.P. Management challenges and therapeutic advances in congenital adrenal hyperplasia.  Nat Rev Endocrinol   18,  337–352 (2022).  null

01Jun2022

First patient dosed in pivotal Phase 3 CONnECT clinical trial for US and Japanese markets

Headline data from CONnECT is anticipated in 2024 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the first patient has been dosed in its Phase 3 pivotal clinical trial of hydrocortisone modified-release hard capsules (DNL-0200 – approved in Europe and the UK under the commercial name Efmody®) for adults with congenital adrenal hyperplasia (CAH). The pivotal Phase 3 randomised, double-blind, active-controlled, clinical trial, known as CONnECT, is evaluating the efficacy, safety and tolerability of modified-release hydrocortisone compared with immediate-release hydrocortisone replacement therapy in participants aged 16-years and over with CAH. The pivotal study for key US and Japan markets worth together in excess of $100m per annum will recruit up to 150 subjects with CAH who will be treated for a period of 52 weeks in centres across Japan, the US, France, and Turkey. The study is anticipated to take up to one year to recruit all patients, with subsequent data readout anticipated in 2024. The study is being conducted under a Special Protocol Assessment (SPA) that has been agreed with the US FDA. The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that would support the regulatory submission for drug approval. DNL-0200 is a preparation of hydrocortisone that has been specifically designed for patients with diseases of cortisol deficiency such as CAH and is currently approved as the only near physiological cortisol replacement treatment for CAH in Europe and the UK. Richard Bungay, Interim Chief Executive Officer of Diurnal, commented: “I am delighted that we have dosed the first patient in this important clinical trial. CONnECT builds on knowledge gained from our European study for DNL-0200, to date the largest ever completed study in CAH, and as the first blinded study, CONnECT should prove to be the definitive evidence for optimal treatment of patients with CAH.” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Richard Bungay, Interim Chief Executive Officer Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker) +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea, William Palmer-Brown Corporate Broking: Nick Adams, Nick Harland FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Vane Percy & Roberts (Medical Communications) +44 (0) 173 782 1890 Simon Vane Percy Notes to Editors About congenital adrenal hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (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 issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroid) preparations including hydrocortisone, dexamethasone, prednisolone and prednisone in the US, with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect between 1 in 10,000 and 1 in 15,000 individuals globally. About DNL-0200 (modified-release hydrocortisone) DNL-0200 is a modified-release oral formulation of hydrocortisone that is designed to match the normal serum levels of the endogenous cortisol circadian rhythm by replicating the normal overnight rise in serum cortisol levels and providing physiological levels upon waking. It is anticipated that providing a near physiological circadian rhythm of cortisol will improve health outcomes in patients with diseases of cortisol deficiency such as CAH and adrenal insufficiency (AI) who are receiving glucocorticoid replacement therapy. DNL-0200 has been extensively studied in 239 human subjects who have taken part in clinical trials in Europe and the US. DNL-0200 (commercial name Efmody®) was approved by the European Commission in May 2021 and by the UK Medicines and Healthcare Regulatory Agency (MHRA) in July 2021 as a replacement treatment in patients suffering from the genetic condition congenital adrenal hyperplasia (CAH). Efmody ® is commercially available in both Europe and the UK for the treatment of adolescents (greater than 12 years old) and adults with CAH. The human medicine European Public Assessment Report (EPAR) for Efmody® can be viewed  null  and the Summary of Product Characteristics (SmPC)  null . 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  null Date of Preparation: May 2022 Code: CORP-GLO-0038

23May2022

Diurnal to present research into the treatment of congenital adrenal hyperplasia at 24th European Congress of Endocrinology meeting

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, will be presenting research findings on the treatment and management of Congenital Adrenal Hyperplasia (CAH) at this year’s European Congress of Endocrinology, which takes place 21-24 May 2022 in Milan, Italy. Over the four-day meeting, the following topics will be presented: null null null null null CAH occurs when the production of cortisol from the adrenal gland is limited due to a genetic deficiency. CAH is associated with over-production of male sex hormones resulting in ambiguous genitalia at birth, precocious sexual development, infertility in men and women, and increased mortality through adrenal crisis. Around 450,000 people globally are estimated to be living with a CAH disorder yet there is no standard treatment. Instead, a variety of steroids are used but data shows around two thirds of people living with CAH still have problems with disease control  null . “Diurnal is committed to supporting research into diseases of cortisol deficiency, and developing solutions to support patients with these life-long disorders,” said Richard Bungay, Interim Chief Executive Officer of Diurnal. “The ECE meeting marks a significant opportunity to contribute to the discussion by the medical community of recent research and developments in an area which has historically had very few advances. The Diurnal team is excited to be part of this event of as we continue to focus on progress in the treatment and management of diseases of cortisol deficiency.” For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Richard Bungay, Interim Chief Executive Officer Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker) +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea, William Palmer-Brown Corporate Broking: Nick Adams, Nick Harland FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis 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 null null Mallappa, A., Merke, D.P. Management challenges and therapeutic advances in congenital adrenal hyperplasia.  Nat Rev Endocrinol   18,  337–352 (2022).  null Date of Preparation: May 2022 Code: CORP-GLO-0036

25Apr2022

Efmody® distribution and marketing agreement signed with EffRx for Switzerland

Extends Company’s existing agreement with EffRx for Alkindi® in Switzerland EffRx to submit Market Authorisation Application for Efmody® to Swissmedic in H2 2022 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has extended its distribution and marketing agreement with EffRx Pharmaceuticals (“EffRx”) in Switzerland to now include Efmody® (hydrocortisone modified-release hard capsules). Under the agreement signed in October 2020, EffRx already holds the exclusive rights to market and distribute Alkindi® (hydrocortisone granules in capsules for opening) in Switzerland. Alkindi® was approved by Swissmedic in November 2021. EffRx intends to submit a Market Authorisation Application (MAA) to Swissmedic for the registration of Efmody® as treatment for adolescent and adult patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH) in Switzerland during the second half of 2022. The MAA submission to Swissmedic for Efmody® will be based on the European regulatory dossier and published clinical trial data, with EffRx expecting potential market launch in Switzerland in 2024. Under the terms of the agreement, EffRx will receive the exclusive rights to market and sell Efmody® in Switzerland once registered. According to the Company’s estimates, there are approximately 450 patients in Switzerland suffering from CAH. Efmody® is a modified-release preparation of hydrocortisone that has been specifically designed for the treatment of patients with CAH, a rare condition caused by a genetic deficiency of adrenal enzymes. In May 2021, Efmody® was granted marketing authorisation in the European Union and was subsequently launched by the Company in Germany, Austria and the UK in September 2021. On successful approval in Switzerland, Diurnal will provide Efmody ® to EffRx for sale from its established European supply chain. Richard Bungay, Interim Chief Executive Officer of Diurnal, commented: “We are pleased to deepen our relationship with EffRx to include the distribution and marketing of Efmody® in Switzerland. We have been impressed by the progress EffRx has made with the regulatory approval and reimbursement of Alkindi® and look forward to continuing to work with them as they prepare to submit an MAA to Swissmedic for Efmody®.” Lorenzo Bosisio, Chief Executive Officer of EffRx, commented: “We are excited to sign this additional agreement with Diurnal, enabling us to build on the momentum we have achieved with Alkindi ® in Switzerland following approval from Swissmedic in November 2021. We believe the unique release profile of Efmody ®, that mimics the body’s natural cortisol circadian rhythm, could have a genuine impact on CAH patients’ symptoms. We are aligned with Diurnal’s strategy to address the unmet medical need in patients suffering from diseases of cortisol deficiency and look forward to working with the Diurnal team to bring Efmody® to patients suffering from CAH in Switzerland.” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Richard Bungay, Interim Chief Executive Officer and Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker) +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea, William Palmer-Brown Corporate Broking: Nick Adams, Nick Harland FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About congenital adrenal hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (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 issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroid) preparations including hydrocortisone, dexamethasone, prednisolone and prednisone in the US, with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 16,000 patients in the US, with over 400,000 in the rest of the world. About Efmody® (hydrocortisone modified-release hard capsules) Efmody® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody® is congenital adrenal hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The MHRA and European Commission marketing authorisation approval of Efmody ® was based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, including sites in Great Britain, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody ® over an extended period, with a number of patients on this trial having been treated for over five years. Summary of Product Characteristics (SmPC) for UK (Northern Ireland) can be found  null . 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  null About EffRx Pharmaceuticals EffRx Pharmaceuticals is a commercial-stage pharmaceutical company focused on the late-stage development and commercialisation of prescription medications for niche and orphan indications. The business model is centred around providing superior clinical and commercial value propositions for physicians, payers and patients. EffRx pro-actively seeks in-licensing opportunities for Europe in niche therapeutic areas, with a primary interest for rare diseases, where EffRx has received an orphan drug designation (ODD) from the US Food and Drug Administration (FDA). For further information about EffRx Pharmaceuticals, please visit  null Date of Preparation: April 2022 Code: CORP-EU-0034

20Apr2022

Distribution agreement signed with Er-Kim for Greece, Cyprus and Malta targeting a market opportunity of approximately €7m

Deepens existing distribution relationship with Er-Kim covering Alkindi ® and Efmody® In line with Company’s strategy to commercialise products outside of key markets; Alkindi® and Efmody® now being commercialised in 20 countries in the European Union Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has extended its distribution agreement with Er-Kim to include the distribution and marketing of Alkindi® (hydrocortisone granules in capsules for opening) and Efmody® (hydrocortisone modified-release hard capsules) in Greece, Cyprus and Malta. Under the terms of the agreement, Er-Kim will receive the exclusive rights to distribute and market Alkindi® and Efmody® in Greece, Cyprus and Malta. The Company estimates the combined market opportunity for these three countries to be approximately €7m in paediatric adrenal insufficiency (AI) and adult congenital adrenal hyperplasia (CAH). This latest agreement deepens the Company’s existing relationship with Er-Kim, who also hold the rights to distribute and market Alkindi ® and Efmody® in Turkey, Romania and Bulgaria. Alkindi® is the first licensed preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from AI, including the related CAH. This distribution agreement further extends the global rollout of Alkindi®, which is already approved in the UK, the European Economic Area, Israel, Australia, Switzerland and the US (where it is known as Alkindi Sprinkle ®). Efmody® is a modified-release preparation of hydrocortisone that has been specifically designed for the treatment of patients with CAH, a rare condition caused by a genetic deficiency of adrenal enzymes. In May 2021, Efmody® was granted marketing authorisation in the European Union and was launched by the Company in Germany, Austria and the UK in September 2021. In line with the Company’s commercialisation strategy and other global distribution agreements, Diurnal will provide Alkindi® and Efmody® from its established European supply chain for sale by Er-Kim. Richard Bungay, Interim Chief Executive Officer and Chief Financial Officer of Diurnal, commented: “We are excited to strengthen our partnership with Er-Kim to now include Greece, Cyprus and Malta. Following this latest agreement with Er-Kim, we are pleased that the Company’s commercial footprint now reaches 70% of the European Union population.” Cem Zorlular, Chairman and Chief Executive Officer of Er-Kim, commented: “We are pleased to expand our collaboration with Diurnal after a year of working relentlessly to execute on our shared vision of addressing unmet rare endocrine conditions in Turkey, Romania and Bulgaria. We are very excited to have the opportunity to now provide market access to much needed paediatric and adult cortisol deficiency treatments in Greece, Malta, Cyprus.” This is a business press release and Regulatory News Service (RNS) announcement containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Richard Bungay, Interim Chief Executive Officer and Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker) +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea, William Palmer-Brown Corporate Broking: Nick Adams, Nick Harland FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About Paediatric Adrenal Insufficiency Paediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone). About Alkindi® (hydrocortisone granules in capsules for opening) Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients suffering from diseases due to cortisol deficiency including paediatric AI and congenital adrenal hyperplasia (CAH). AI requires life-long treatment and Diurnal's novel approach to product development has the potential to significantly improve these young patients' lives. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi® is approved and known as Alkindi Sprinkle® in the US where it is licensed and marketed by Eton Pharmaceuticals. Alkindi® is also approved in Israel, Australia and Switzerland. About congenital adrenal hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (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 issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroid) preparations including hydrocortisone, dexamethasone, prednisolone and prednisone in the US, with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 16,000 patients in the US, with over 400,000 in the rest of the world. About Efmody® (hydrocortisone modified-release hard capsules) Efmody® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody® is congenital adrenal hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The MHRA and European Commission marketing authorisation approval of Efmody® was based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, including sites in Great Britain, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody ® over an extended period, with a number of patients on this trial having been treated for over five years. Summary of Product Characteristics (SmPC) for UK (Northern Ireland) can be found  null . 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  null About Er-Kim ER-Kim has been serving as the regional affiliate for the world's most important pharmaceutical and biotechnology companies since 1981. Today, ER-Kim remains one of the oldest and largest companies delivering novel treatments to patients in Central and Eastern Europe (CEE), the Mediterranean and Turkey. For further information about Er-Kim, please visit  null Date of Preparation: April 2022 Code: CORP-EU-0033

04Apr2022

Directorate Change and Management Updates

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that following 14 years with the Company, Martin Whitaker has decided to step down as Chief Executive Officer (CEO) and a member of the Board of Diurnal, with immediate effect, to enable him to pursue other business opportunities. Consistent with the Company’s vision to become a leading specialty commercial endocrinology company, the Board has initiated an international search for a new CEO with strong commercial credentials. Richard Bungay, currently the Company’s Chief Financial Officer (CFO), who has been with the Company for more than five years, will immediately assume the role of Interim CEO until a successor is appointed. Additionally, David Bevan, who was appointed Interim Head of Commercial in November   2021, has been promoted to the newly created role of Chief Business Officer. David has over 30 years of pharmaceutical expertise with a broad base of general management, sales, marketing and commercial experience, in large and medium-sized pharmaceutical companies with Global, EU and UK responsibility. Following these changes Diurnal’s Senior Management Team will consist of five people: Richard Bungay – Interim CEO and CFO, Dr Richard Ross – Chief Scientific Officer, Dr John Porter – Chief Medical Officer, Stewart Jones – Operations Director and David Bevan – Chief Business Officer. Anders Härfstrand, Non-Executive Chairman of Diurnal, commented: “On behalf of the Board, I would like to thank Martin for his leadership and commitment in the development of ground-breaking technologies and wish him well in his future endeavours. “The Company continues to progress its vision to become a leading commercial specialty endocrinology company. Therefore, the Board has initiated the search for a new CEO with strong market access and commercial experience who will lead the Company through its next phase of growth.” Martin Whitaker, Chief Executive Officer of Diurnal, commented: “I am proud of the excellent progress the team at Diurnal has achieved over the past ten years in developing therapies for patients suffering from rare endocrine disorders with an unmet need. Diurnal is now poised for its next stage of growth in becoming a fully integrated commercial business, and I remain confident in the long-term prospects of the Company." This announcement contains inside information for the purposes of the UK Market Abuse Regulation (UK MAR). For   further   information,   please   visit   null or   contact: Diurnal Group plc +44 (0)20 3727 1000 Richard Bungay, Interim Chief Executive Officer and Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker) +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea, William Palmer-Brown Corporate Broking: Nick Adams, Nick Harland FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis 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 null Code: NPR-GLO-0001                              Date of Preparation: April 2022

30Mar2022

Distribution agreement signed with Vector Pharma for Alkindi®

Exclusive partnership covers 14 countries across the Middle East and North Africa Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces a distribution agreement with Vector Pharma FCZO (“Vector Pharma”), a leading full-service distributor, for the distribution of Alkindi® (hydrocortisone granules in capsules for opening) across the Middle East and North Africa regions. Under the terms of the distribution agreement, Vector Pharma will receive the exclusive rights to distribute Alkindi® in Morocco, Tunisia, Algeria, Libya, Egypt, Saudi Arabia, Qatar, United Arab Emirates, Bahrain, Kuwait, Oman, Lebanon, Jordan and Iraq. Through Vector Pharma, Alkindi® will be available to paediatric patients who qualify through applicable Early Access programmes for patients with diseases of cortisol deficiency who have no other treatment options. This latest distribution agreement for the Company will further extend the global rollout of Alkindi®, which is already approved in the UK, European Economic Area, Israel, Australia, and the US (where it is known as Alkindi Sprinkle®). Alkindi® is the first licensed preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from adrenal insufficiency (AI), including the related condition congenital adrenal hyperplasia (CAH). In accordance with the Company’s existing distribution agreements, Diurnal will provide Alkindi® from its established European supply chain for sale by Vector Pharma. It is expected that Alkindi® will be available to patients in the Middle East and North Africa during Q2 2022. This agreement adds to the Company’s ongoing strategy for commercialisation of its lead products beyond the larger European markets, where Diurnal markets its products itself, through entering into international distribution agreements with companies focused on niche and orphan conditions. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We   are   pleased   to   be   working   with   Vector   Pharma   to   extend   the   availability   of   Alkindi   ®   to   a   large   geographic   region   where   there   is   a   significant   unmet   patient   need   in   children   suffering   from   AI   and   CAH.   Working   with   Vector   Pharma   will   further   broaden   the   future   availability   of   Alkindi   ®   outside   of   our   core   markets   and   we   believe   that   Vector   Pharma   is   well-positioned   to   distribute   Alkindi   ®   across   the   14   counties   in this   agreement and   to   ensure   it   reaches key healthcare providers and patients.” Samer Semaan, Managing Director of Vector Pharma, commented: “I   am   excited   to   announce   this   regional   distribution   agreement   between   Vector   Pharma   and   Diurnal.   Congenital   adrenal   hyperplasia   is   the   most   common   form   of   paediatric   AI   affecting   young   patients   throughout the Middle East and North Africa, and we hope that   allowing both patients and prescribers   access   to   this important therapy   will   make   a difference in   the   lives   of families   throughout   the   region.” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of the UK Market Abuse Regulation (UK MAR). For   further   information,   please   visit   null 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 Joint Corporate Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker) +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea, William Palmer-Brown Corporate Broking: Nick Adams, Nick Harland FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About Alkindi® (hydrocortisone granules in capsules for opening) Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients suffering from diseases due to cortisol deficiency including paediatric AI and congenital adrenal hyperplasia (CAH). AI requires life-long treatment and Diurnal's novel approach to product development has the potential to significantly improve these young patients' lives. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi® is approved and known as Alkindi Sprinkle® in the US where it is licensed and marketed by Eton Pharmaceuticals. Alkindi® is also approved in Israel and Australia. About Paediatric Adrenal Insufficiency Paediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone). 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  null About Vector Pharma FZCO Vector Pharma was founded in 2019 with the ambition to be the leading full-service distributor for rare diseases, oncology and highly specialised therapeutics in the Middle East, North Africa, and Turkish markets. As the only Trace-certified full-service distributor in the region, Vector has an equal emphasis on patient demand generation through evidence-based medicine, fast track market access solutions, and the highest compliance & ethical standards, all the while striving for the best outcomes for patients, prescribers, and partners. Vector Pharma is also a proud founding member of the World Orphan Drug Alliance (WODA), offering its services together with like-minded sister companies in Switzerland, Central and Eastern Europe, and Latin America. More information can be found at  null Date of Preparation: March 2022 Code: CORP-GLO-0028

22Mar2022

Interim Results for the Six Months Ended 31 December 2021

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its results for the six months ended 31 December 2021 (the “Period”) and follows the publication of a trading update on 26 January 2022. Operational highlights null o  Alkindi®  (hydrocortisone granules in capsules for opening) null null o  Efmody®  (modified-release hydrocortisone) null null null o Continued expansion of the Company's global footprint through distribution agreement with ExCEEd Orphan for Alkindi® and Efmody® in Central and Eastern Europe (CEE) countries null o  DNL-0200  (modified-release hydrocortisone – previously referred to as Chronocort®) null null null null o  DNL-0300  (native oral testosterone formulation) null Financial highlights · Total revenue for the Period increased to £2.13m, representing year-on-year growth of 75% (six months ended 31 December 2020: £1.21m) null o Continued growth achieved in core markets (UK, Germany, Italy and Austria) with sales of £1.28m for the Period (six months ended 31 December 2020: £0.92m), an increase of 39% year-on-year despite the continued impact of the Covid-19 pandemic on patients’ ability to visit hospitals and consequently physicians’ ability to switch these patients to Alkindi ® null null null null Corporate highlights null Martin Whitaker, PhD, Chief Executive Officer of Diurnal, commented: “Diurnal has continued to make incremental progress during the Period in making Alkindi® available to patients around the world. We are pleased with Alkindi®'s growth in revenues, despite the continued impact of pandemic-related restrictions in Europe and look forward to this growth accelerating as hospitals begin to return to normal. Further growth is expected from launches of Alkindi ® by our partners in new markets over the coming period and we look forward to continuing to expand our commercial footprint through further distribution agreements.” “In early March 2022, we were disappointed to receive the SMC decision not to recommend Efmody® for automatic reimbursement in Scotland, which will impact near-term revenues in the UK. Looking forward, our near-term focus is on the continued commercial roll-out of Efmody ® for CAH in other major European territories and ensuring the Company has adequate resources to maximise the commercial opportunity. In the longer-term, we are focused on the generation of new clinical data from the CHAMPAIN and CONnECT studies, which we believe will highlight the value and benefits of physiological cortisol replacement with Efmody® in both CAH and AI globally and provide additional data for continued reimbursement discussions in Europe” Diurnal plans to hold its R&D Day for analysts and institutional investors on 7 September 2022, having re-scheduled the event from February 2022. The R&D Day will be held in-person at FTI Consulting, 200 Aldersgate, Aldersgate Street, London, EC1A 4HD, with the option to attend virtually. To register to attend in person, or to receive a link to the webcast, please contact  null . As reported at the Company's results for the year ended 30 June 2021 on 14 September 2021, Diurnal's financial year end has been changed to 31 December, with the next statutory reporting due for the 18-month period to 31 December 2022. In the Interim Results: · “bn”, “m” and “k” represent billion, million and thousand, respectively · “Group” is the Company and its subsidiary undertakings, Diurnal Limited and Diurnal Europe B.V. This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of the UK Market Abuse Regulation (UK MAR). For further information, please visit  null  or contact: Diurnal Group plc  +44 (0)20 3727 1000 Martin Whitaker, CEO Richard Bungay, CFO Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker)  +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker)  +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea Corporate Broking: Nick Adams FTI Consulting (Media and Investor Relations)  +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis 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 null Forward looking statements Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the Company believe that the expectations reflected in these statements are reasonable but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward-looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods. View full document: null Date of Preparation: March 2022             Code: CORP-GLO-0026

07Mar2022

Scottish Medicines Consortium Update

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, provides an update on the status of reimbursement of Efmody® (modified-release hydrocortisone) for NHS Scotland. The Company notes that, while Efmody® remains available to prescribe in Scotland, the Scottish Medicines Consortium (SMC) has today announced that Efmody® has not been recommended for automatic reimbursement within NHS Scotland as a treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. Diurnal will generate further clinical and health-economic data to support a re-submission to the SMC at the earliest possible opportunity. Diurnal will continue to make Efmody available to patients in Scotland and is committed to patient access through a number of means including support for clinicians wishing to utilise Efmody® in their clinics. As a result of the SMC decision, Diurnal’s Efmody® sales forecasts for the UK will be impacted reflecting the reliance of a number of healthcare clinical commissioning groups on the SMC assessment. However, the Board still expects strong sales growth in total product sales in excess of 100% for the 12-month period ended 30 June 2022 compared to the prior period as the commercial roll out of Alkindi® and Efmody ® continues across Europe. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “Diurnal remains firmly committed to making Efmody® available to Scottish patients and the Company will work with clinicians and patient groups to achieve this goal. Further data to support Efmody®’s clinical benefit are being generated from ongoing clinical trials with Efmody® and Diurnal will work to make this available to the SMC via a resubmission as soon as possible.” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of the UK Market Abuse Regulation (UK MAR). For further information, please visit  null  or contact: Diurnal Group plc  +44 (0)20 3727 1000 Martin Whitaker, CEO Richard Bungay, CFO Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker)  +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker)  +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea Corporate Broking: Nick Adams FTI Consulting (Media and Investor Relations)  +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About congenital adrenal hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (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 issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroid) preparations including hydrocortisone, dexamethasone, prednisolone and prednisone in the US, with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 16,000 patients in the US, with over 400,000 in the rest of the world. About Efmody® (hydrocortisone modified-release hard capsules) Efmody ®  is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody ®  is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody ®  has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The MHRA and European Commission marketing authorisation approval of Efmody ® was based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, including sites in Great Britain, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody ® over an extended period, with a number of patients on this trial having been treated for over 5 years. Summary of Product Characteristics (SmPC) for UK (Northern Ireland) can be found  null . 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  null Date of Preparation: March 2022 Code: CORP-EU-0030

02Mar2022

Regulatory update on oral native testosterone

Targeting H2 2022 start for Phase 1 study with DNL-0300 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has received feedback from the US Food and Drug Administration (FDA) for its native oral testosterone treatment (DNL-0300, previously referred to as DITEST™) in response to the Company’s Investigational New Drug (IND) application submitted towards the end of January 2022. As announced in July 2020, the FDA has previously indicated that the registration programme for DNL-0300 for the treatment of male hypogonadism can progress via the 505(b)(2) regulatory pathway, which means potentially only two further clinical studies are required before filing for market approval via a New Drug Application (NDA): a Phase 1 multiple-ascending dose (MAD) study followed by a single pivotal Phase 3 trial. In the latest feedback, the FDA has stated that Diurnal’s Phase 1 study can proceed subject to a protocol modification, primarily relating to additional clinical safety data from the two lowest dose groups. Diurnal expects to file an amended protocol for the MAD study as soon as possible with a view to initiating dosing in H2 2022. DNL-0300 will remain on partial clinical hold until the revised protocol has been agreed with the FDA. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are pleased to have received greater visibility and certainty regarding the exact nature of studies required to satisfy the FDA as we move DNL-0300 towards registrational submission in the US. We will file an amended protocol in the coming weeks and we look forward to starting the next study for our native oral testosterone product in H2 2022.” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of the UK Market Abuse Regulation (UK MAR). For further information, please visit  null  or contact: Diurnal Group plc  +44 (0)20 3727 1000 Martin Whitaker, CEO Richard Bungay, CFO Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker)  +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker)  +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea Corporate Broking: Nick Adams FTI Consulting (Media and Investor Relations)  +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About Hypogonadism Hypogonadism results from failure of the testes (primary gonadal failure) or from failure of stimulation by the pituitary (secondary hypogonadism) resulting in testosterone insufficiency. In primary hypogonadism, failure of the testes can be congenital (inherited) or acquired during life due to a variety of causes (failure of the testes to descend into the scrotum, inflammation due to infections such as mumps, chemotherapy or radiotherapy affecting the testes, and following removal of the testes for testicular tumours). Secondary hypogonadism usually results from a benign tumour of the pituitary gland that causes hypopituitarism and may occasionally be congenital. The hypogonadism market is a large and fragmented market. Diurnal estimates that in Europe and the US the market opportunity is around $5 billion per annum. Topical (gel) formulations are the current market leaders due to low bioavailability of testosterone in the body when administered by the oral route. However, these topical formulations have compliance and administration issues. Other testosterone replacement therapies for hypogonadism include intramuscular injections, testosterone patches and the only currently available oral forms are modified testosterones (such as testosterone undecanoate) that have limited label scope, well-documented pharmacokinetic variability, a requirement to be taken with a high fat meal and safety concerns. Therefore, Diurnal believes that there is a patient need for an oral (native) testosterone preparation . About native oral testosterone Native oral testosterone (DNL-0300 previously referred to as DITEST™) is a novel formulation developed by Diurnal comprising native testosterone adapted for oral delivery for the treatment of hypogonadism. The main challenge with oral delivery of native testosterone is that, whilst the hormone undergoes rapid and complete absorption, there is considerable metabolism in both the gut wall and during first hepatic pass which accounts for up to 98% reduction in testosterone bioavailability (the amount of drug in the body that is able to have an active effect). Diurnal's approach is a proprietary lipid-based formulation that aims to provide improved bioavailability of testosterone. An additional potential feature of the native testosterone formulation demonstrated in both preclinical studies and now in this clinical study is that it shows similar absorption and bioavailability in both the fed and fasted state and therefore potentially can be taken without a substantial meal, which is a requirement with many alternative oral modified-testosterone formulations. Patents protecting DNL-0300 have already been granted in the US, Europe and other major territories worldwide. 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  null Date of Preparation: March 2022 Code: CORP-EU-0028

10Feb2022

First patient dosed in Phase 2 clinical trial with modified-release hydrocortisone in adults with adrenal insufficiency

Data from CHAMPAIN European study expected in H2 2022 Positive data could lead to regulatory approval in AI in 2023 Addressable market seven times larger than CAH Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the first patient has been dosed in its Phase 2 European clinical trial of modified-release hydrocortisone (DNL-0200 – previously referred to as Chronocort®) for a line extension in adrenal insufficiency (AI). AI represents a significant market opportunity for the Company of approximately $1.9bn across Europe and the UK. The Phase 2 study will evaluate the efficacy, safety and tolerability of modified-release hydrocortisone versus Plenadren® in AI (CHAMPAIN). The study will recruit up to 50 subjects with primary AI who will be followed for a period of 16 weeks across centres in Germany and the UK. The CHAMPAIN study is anticipated to take six months to complete with data readout expected in H2 2022. The results of the study will support the Company’s discussions with both the European Medicines Agency (EMA) and the UK Medicines and Healthcare Regulatory Agency (MHRA) to seek market authorisations for the product in adult AI in Europe and the UK. Modified-release hydrocortisone is a preparation of hydrocortisone that has been specifically designed for patients with diseases of cortisol deficiency such as AI and additionally the condition of congenital adrenal hyperplasia (CAH) for which it is approved in Europe and the UK (under the commercial name Efmody®). AI is an orphan condition caused by inadequate production of steroid hormones in the cortex of the adrenal glands. AI can result in severe fatigue and, if left untreated, adrenal crisis that may be life threatening. AI is estimated to affect 298,000 patients in Europe and the UK. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are pleased to have dosed our first patient in the CHAMPAIN Phase 2 study for adults with AI as we seek to explore the efficacy of modified-release hydrocortisone in diseases of cortisol deficiency. There is a high unmet need for adult patients suffering from AI across Europe with current treatment options leading to poor quality of life. We believe modified-release hydrocortisone has the potential to replicate the physiological overnight rise of cortisol in these patients and we look forward to the data readout from the CHAMPAIN study in H2 2022.” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null  or contact: Diurnal Group plc  +44 (0)20 3727 1000 Martin Whitaker, CEO Richard Bungay, CFO Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker)  +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker)  +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea Corporate Broking: Nick Adams FTI Consulting (Media and Investor Relations)  +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About adrenal insufficiency Adrenal insufficiency (AI) is an orphan condition caused either by failure of the adrenal gland to produce cortisol (primary AI) or can result from many factors that lead to suppression of the hypothalamic- pituitary axis (secondary AI). The result is a decrease / absence of cortisol production resulting in a number of comorbidities for patients such as lack of energy, weakness and a low mood. AI may also lead to adrenal crisis, particularly during times of increased cortisol requirements (e.g. surgery, infection, or trauma) as patients are unable to mount a stress response. Life-threatening symptoms such as severe dehydration, hypotension, hypovolaemic shock, altered consciousness, seizures, stroke, or cardiac arrest may develop; if left untreated, adrenal crisis may lead to death or permanent disability. The condition is estimated to affect 298,000 patients in Europe and the UK. Current therapy in Europe and the UK for AI either uses generic hydrocortisone or Plenadren® (modified-release hydrocortisone tablets). However, these preparations are unable to replicate the physiological overnight rise of cortisol in AI patients leading to fatigue and poor quality of life, especially in the morning. About DNL-0200 (modified-release hydrocortisone hard capsules) DNL-0200 is a modified-release oral formulation of hydrocortisone that is designed to match the normal serum levels of the endogenous cortisol circadian rhythm by replicating the normal overnight rise in serum cortisol levels and providing physiological levels upon waking. It is anticipated that providing a near physiological circadian rhythm of cortisol will improve health outcomes in patients with adrenal insufficiency (AI) who are receiving glucocorticoid replacement therapy. DNL-0200 has been extensively studied in 239 human subjects who have taken part in clinical trials in Europe and the US. DNL-0200 (commercial name Efmody®) was approved by the European Commission in May 2021 and by the UK Medicines and Healthcare Regulatory Agency (MHRA) in July 2021 as a replacement treatment in patients suffering from the genetic condition congenital adrenal hyperplasia (CAH). Efmody ® is commercially available in both Europe and the UK for the treatment of adolescents (greater than 12 years old) and adults with CAH. The human medicine European Public Assessment Report (EPAR) for Efmody® can be viewed  null  and the Summary of Product Characteristics (SmPC)  null . 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  null Date of Preparation: February 2022 Code: CORP-EU-0026

26Jan2022

Trading update

Strong sales growth (+75%) driven by good Alkindi® performance and first sales of Efmody® Initial launches of Efmody® in Germany, UK and Austria in line with the Company’s expectations Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today provides an unaudited trading update for the six months ended 31 December 2021 (“Period”). Financial highlights: Revenue · Total revenues for the Period increased to £2.16m, representing year-on-year growth of 75% (six months ended 31 December 2020: £1.21m). null o Continued growth achieved in core markets (UK, Germany, Italy and Austria) with sales of £1.28m for the Period (six months ended 31 December 2020: £0.92m), increasing by 39% year-on-year despite the continued impact of the Covid-19 pandemic on patients’ ability to visit hospitals and consequently physicians’ ability to switch these patients to Alkindi ®. o Series of Alkindi® launches planned by Diurnal’s global distribution partners in the first half of calendar year 2022, which are expected to further underpin the growth of Alkindi®. null o Efmody® sales are expected to accelerate significantly in the first half of calendar year 2022, as the Company begins to receive pricing and formulary approvals in its target European markets. Cash null Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are pleased that Alkindi® revenues have shown good growth, despite the continued challenges in access to hospitals due to Covid-19 pandemic restrictions, impacting both patients and our commercial team. We are also pleased with the continued progress of our commercialisation partners for Alkindi® and look forward to an increased contribution from territories outside of our core markets as commercial launch activities progress during 2022. We are now focused on the commercial launch and roll-out of Efmody® and expect to initiate commercial launch in key European markets during 2022 as we complete local pricing and reimbursement activities.” As reported at the Company’s results for the year ended 30 June 2021 on 14 September 2021, Diurnal’s financial year end has been changed to 31 December, with the next statutory reporting due for the 18-month period to 31 December 2022. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null  or contact: Diurnal Group plc  +44 (0)20 3727 1000 Martin Whitaker, CEO Richard Bungay, CFO Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker)  +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker)  +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea Corporate Broking: Nick Adams FTI Consulting (Media and Investor Relations)  +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. 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 null Date of Preparation: January 2022                     Code: CORP-GB-0165

11Jan2022

Operational update - Jan 2022

First clinical trial sites initiated in both CONnECT and CHAMPAIN studies for Chronocort® DITEST™ IND application to be submitted during January 2022 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, provides an operational update on its ongoing clinical trial activity. Operational updates CHAMPAIN:  Chronocort® (hydrocortisone modified-release hard capsules) Phase 2 line extension study in adrenal insufficiency (AI) in Europe. The Directors believe this study will facilitate submission of a line extension to AI in Europe (and support any US regulatory submission in due course). AI represents a significant market opportunity of approximately $2.9bn across Europe and the US. null null null CONnECT:  Chronocort® Phase 3 registrational study in congenital adrenal hyperplasia in US and Japan null null null null DITEST™:  Investigational New Drug (IND) application in US null A further detailed update on clinical trial activities will be provided at the Company’s R&D Day taking place in London (UK) on 02 February 2022. To register to attend in person, or to receive a link to the webcast, please contact  null . Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are pleased to be able to demonstrate continued advancement of our clinical trial activities despite recent headwinds caused by the Omicron COVID-19 variant and its impact on healthcare systems around the world. We remain hopeful that as COVID-19 pressures begin to ease, recruitment of patients into the clinic will accelerate significantly. In addition, we look forward to providing a full R&D update at the beginning of February 2022.” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null null null  or contact: Diurnal Group plc  +44 (0)20 3727 1000 Martin Whitaker, CEO Richard Bungay, CFO Panmure Gordon (UK) Limited (Nominated Adviser and Joint Corporate Broker)  +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden Stifel Nicolaus Europe Limited (Joint Corporate Broker)  +44 (0) 20 7710 7600 Healthcare Investment Banking: Nicholas Moore, Samira Essebiyea Corporate Broking: Nick Adams FTI Consulting (Media and Investor Relations)  +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About the FDA’s Special Protocol Assistance The SPA process documents the FDA’s official evaluation and written guidance on the design and size of proposed protocols and agreement that the design and planned analysis of a study can adequately address objectives in support of a regulatory submission. Final determinations for marketing application approval, however, are made after a complete review of a marketing application and are based on the entire data in the application. The agreed SPA may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. About congenital adrenal hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (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 issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroid) preparations including hydrocortisone, dexamethasone, prednisolone and prednisone in the US, with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 16,000 patients in the US, with over 400,000 in the rest of the world. About adrenal insufficiency Adrenal insufficiency (AI) is an orphan condition caused either by failure of the adrenal gland to produce cortisol (primary AI) or can result from many factors that lead to suppression of the hypothalamic-pituitary axis (secondary AI). The result is a decrease/absence of cortisol production resulting in a number of comorbidities for patients such as lack of energy, weakness and a low mood. AI may also lead to adrenal crisis, particularly during times of increased cortisol requirements (e.g. surgery, infection, or trauma) as patients are unable to mount a stress response. Life-threatening symptoms such as severe dehydration, hypotension, hypovolaemic shock, altered consciousness, seizures, stroke, or cardiac arrest may develop; if left untreated, adrenal crisis may lead to death or permanent disability. The condition is estimated to affect 298,000 patients in Europe and the UK. Current therapy in Europe and the UK for AI either uses generic hydrocortisone or Plenadren® (modified-release hydrocortisone). However, these preparations are unable to replicate the physiological overnight rise of cortisol in AI patients leading to fatigue and poor quality of life, especially in the morning. About Chronocort® (hydrocortisone modified-release hard capsules) Chronocort ®  is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first targeted indication for Chronocort  ®  in the US is congenital adrenal hyperplasia (CAH) in adults. Chronocort ®  has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. Chronocort® (commercial name Efmody®) was approved by the European Commission in May 2021 and by the UK Medicines and Healthcare Regulatory Agency (MHRA) in July 2021 and is commercially available in Europe and the UK. The human medicine European Public Assessment Report (EPAR) for Efmody® can be viewed  null  and the Summary of Product Characteristics (SmPC)  null . 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  null Date of Preparation: January 2022 Code: CORP-GB-0164

Diurnal Limited (Company Number: 05237326) is registered in England & Wales. Registered office: Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, UK.