Welcome to Diurnal

Dedicated to bringing products to the global endocrine market

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.

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Mission Statement

To address the major unmet clinical and patient needs in endocrinology by creating products for the lifelong treatment of chronic conditions.

Latest News

14Sep2021

Full Year Results for the year ended 30 June 2021

Results for the year ended 30 June 2021 Significant progress made during the year with two major regulatory approvals Alkindi® growth of 18% in core markets despite continued impact of Covid-19 on hospital visits Post-period, launch of Efmody® in Europe, Diurnal’s second product on the market following Alkindi® Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its audited results for the year ended 30 June 2021. Operational highlights (including post-period): Approved products: Alkindi® (hydrocortisone granules in capsules for opening) · null null null null Efmody® (modified-release hydrocortisone) null null null null null Development products: DITEST™ (native oral testosterone formulation) null Financial overview null null null null null Martin Whitaker, CEO of Diurnal, commented: “Over the past year, Diurnal has continued to make significant progress in its ambition towards becoming a world-leading endocrinology company. We continued to roll-out Alkindi® across Europe and secured FDA approval for the product, which was subsequently launched in the US by our partner Eton. Another key milestone was the approval of our second product, Efmody®, in Europe. The launch is progressing well and  we expect to realise synergies in the utilisation of our existing European commercial infrastructure and supply chain from Alkindi® which we anticipate to lead to the rapid uptake of Efmody® as a new treatment option available for patients suffering from CAH as the launch gains momentum." “In our pipeline, we are excited to progress our development strategy for Efmody® in the US, as well as the clinical development of DITEST™, with an IND application expected to be filed later this year. We continue to believe that Diurnal is well positioned with sufficient cash resources to take our core commercial European cortisol deficiency franchise through to profitability and look forward to reporting on further operational and commercial progress in this current financial period.” Martin Whitaker, Chief Executive Officer, and Richard Bungay, Chief Financial Officer, will provide a live presentation relating to the Company’s financial results today via the Investor Meeting Company platform at 11:00 BST. The online presentation is open to all existing and potential shareholders. Investors can sign up to Investor Meet Company for free and interested parties can register to attend the presentation via the following link: null . In the audited results for the year ended 30 June 2021: null null 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, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis 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. To continue reading the full press release please click null

13Sep2021

Commercial launch of Efmody® in the UK

Commercial launch of Efmody® in the UK Follows recent European launch in Germany and Austria Provides a new treatment option for adult and adolescent patients suffering from CAH in the UK Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces the commercial launch of Efmody® (hydrocortisone modified-release hard capsules) in the United Kingdom as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH). The launch of Efmody® follows its approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain (England, Wales and Scotland) in July 2021. Consistent with the Company’s European commercialisation strategy, Diurnal is marketing Efmody® in the UK with its own salesforce. In parallel to this launch and following the recent launch in Germany and Austria on 1st September, Diurnal is currently in discussions with various health authorities across the European Economic Area to ensure timely launches in other major European countries. Launch stocks of Efmody® have been manufactured in advance of the planned launches in order to provide timely availability of the product, utilising many aspects of the supply chain that have already been established by the Company for Alkindi®. Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, a rare condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. 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 5,000 patients in Great Britain. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are delighted to have launched Efmody® in the UK. Efmody® provides a new treatment option for patients suffering with CAH in Great Britain, and we look forward to being able to provide Efmody® to these patients.” 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, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (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 a rare 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 (steroids 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 41,000 patients in Europe and Great Britain, 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: September 2021                 Code: CORP-GB-0149

01Sep2021

Diurnal launches Efmody® in Germany and Austria

Diurnal launches Efmody® in Germany and Austria Represents Diurnal’s second marketed product in Europe Provides a new treatment option for adult and adolescent patients suffering from CAH Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces the launch of Efmody® (hydrocortisone modified-release hard capsules) in Germany and Austria as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH), following approval by the European Commission in May 2021. Following the launch of Alkindi® (hydrocortisone granules in capsules for opening) in Germany in 2018, Efmody® is now the second product that Diurnal has brought to market in Europe. Efmody ® pricing has been published today in the LAUER-TAXE® (the reference for all German pharmacies, insurers and wholesalers) and is in line with the Company’s expectations. In addition, the pricing for Efmody® in Austria has also been published in the Warenverzeichnis (the reference for all Austrian pharmacies, insurers and wholesalers) managed by the Apotheker-Verlages. As part of the pan-European commercialisation programme for Efmody®, Diurnal is currently in discussions with various health authorities across the European Economic Area to ensure timely launches in other major European countries. As previously announced, the Company intends to mirror its strategy for Alkindi® by commercialising the product itself in core European markets given the concentrated prescribing base, relationships already established from Alkindi®, and to retain the full value of the product. Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, a rare condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. 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 36,000 people in the European Economic Area. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “With the launch of Efmody® in Germany and Austria, Diurnal has achieved a significant milestone through the commercialisation of our second product. Importantly, the launch of Efmody® alongside our first product Alkindi®, means that patients in Europe with CAH will now have the option of lifelong treatment with products specifically designed for their disease. We look forward to expanding our reach within Europe in the coming months and helping to provide treatment to these patients where there is a significant unmet need.” 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, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (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 41,000 patients in Europe and the United Kingdom, 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 European Commission approval of Efmody® was based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, 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. 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: September 2021 Code: CORP-GB-0148

12Jul2021

Diurnal receives Special Protocol Assessment Agreement for Chronocort® from the FDA

Pivotal Phase 3 trial expected to commence in the US in H2 2021 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today announces that the US Food and Drug Administration (FDA) has agreed a Special Protocol Assessment (SPA) for Chronocort® (modified-release hydrocortisone) for the design, endpoints and statistical analysis approach of a pivotal study of Chronocort® for the treatment for Congenital Adrenal Hyperplasia (CAH) in the US. The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that would support the regulatory submission for drug approval. The pivotal study is entitled “A randomised, double-blind, active-controlled, Phase 3 study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16-years and over with Congenital Adrenal Hyperplasia (CAH)” – CONnECT – and is anticipated to start during H2 2021. Study start-up activities have already been commenced by the Company to enable a timely initiation and recruitment of up to 150 subjects with CAH who will be treated for a period of 52 weeks. Chronocort® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, an orphan condition, caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. Diurnal holds the relevant Orphan Drug Designation for use of Chronocort® in CAH in the US. 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. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are pleased to have concluded a series of positive discussions with the FDA around the design of our pivotal Chronocort® study to support a regulatory submission for marketing approval in the US. During the first half of 2021 the Diurnal team has been working hard to complete the required preparation activities for this trial and we look forward to starting this study 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 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, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (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 a rare 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 (steroids 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 approximately 16,000 patients in the US, with over 400,000 in the rest of the world. About Chronocort® (modified-release hydrocortisone) 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 planned indication for Chronocort  ®  in the US is Congenital Adrenal Hyperplasia (CAH) in adults and children older than 16 years of age. 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. Although Chronocort® is still an investigational product in the US, Chronocort® (known in Europe as Efmody®) has already achieved marketing authorisation approval from the European Commission (in the European Economic Area) and the Medicines and Healthcare products Regulatory Agency (in Great Britain). These marketing authorisations for Efmody® are based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, including a site in the US, 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 54 months. Patient retention rates in this study have been high and patients on this trial have, to date, shown sustained benefit from extended Efmody® treatment. 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: July 2021               Code: CORP-GB-0141

02Jul2021

Diurnal receives Marketing Authorisation for Efmody® in Great Britain from the MHRA

Efmody® provides a new treatment option for c.5,000 patients suffering from CAH in GB GB launch of Efmody® expected in Q1 2022 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Marketing Authorisation for Efmody® (hydrocortisone modified-release hard capsules – development name Chronocort®) as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH). The Marketing Authorisation for Efmody® from the MHRA applies in Great Britain (England, Wales and Scotland) and follows the recent approval of the product in the European Economic Area (including Northern Ireland)(EEA) by the European Commission as announced on 28 May 2021. The submission to the MHRA included detailed analysis of data from the Company's Phase 3 study, the largest ever completed interventional clinical trial in CAH involving 122 subjects, and an open-label safety extension study of Efmody®. To facilitate timely commercial availability, Diurnal has already commenced market access activities in Great Britain, with the commercial launch anticipated in Q1 2022. The Company intends to mirror its strategy for Alkindi® (hydrocortisone granules in capsules for opening) by commercialising the product itself in Great Britain as well as other core European markets. Following feedback from the MHRA and consistent with the approach taken in the EEA, the Company has decided not to pursue Orphan Drug Status for Efmody® in Great Britain as it would likely cause a significant delay to the commercial launch. Whilst Orphan Designation provides market exclusivity for 10 years from launch, the Company currently holds granted patents for Efmody® for the treatment of patients with CAH and believes these patents provide sufficient protection for Efmody® until at least 2033 in Great Britain. Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. 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 5,000 patients in Great Britain. Professor Wiebke Arlt, Institute of Metabolism and Systems Research, University of Birmingham, commented: “I am excited to see Efmody® approved in Great Britain as a treatment for patients with CAH, a rare condition where patients and doctors need to face the challenge of deficient cortisol production and adrenal androgen excess. Efmody® has been developed for these patients and I believe this drug approval provides a new option for the treatment of CAH patients, where there is a significant unmet medical need.” Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are pleased to have received approval for Efmody® from the MHRA and look forward to making Efmody® available to CAH patients in Great Britain as the first licensed treatment specifically designed to mimic the physiological circadian rhythm of cortisol. Today’s approval is yet another important step forward for Diurnal as we continue to drive towards becoming the world’s leading specialty endocrinology business.” 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, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (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 a rare 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 (steroids 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 41,000 patients in Europe and Great Britain, 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® is 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 54 months. Patient retention rates in this study have been high and patients on this trial have, to date, shown sustained benefit from extended Efmody® treatment. 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: July 2021               Code: CORP-GB-0137

Diurnal Group plc (Company Number: 09846650) is registered in England & Wales. Registered office: Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, UK.