OREANDA-NEWS. December 23, 2015. Diurnal, the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has today published its Admission Document following a successful 30 million fundraising and has applied for the Admission of its entire issued and to be issued share capital to AIM, a market operated by London Stock Exchange plc ("AIM") ("Admission").  Admission is expected to occur on Thursday, 24th December 2015, under the ticker symbol "DNL".  The nominated adviser and broker to the Company is Numis Securities Limited ("Numis").

The Company has conditionally raised approximately 30 million (?28.4 million net of expenses) by way of a placing of new ordinary shares of 5 pence each in the Company (the "Shares") at 144 pence per Share (the "Placing Price") to institutional and other investors (the "Placing") and through IP2IPO Limited (a subsidiary of IP Group plc) ("IP2IPO") making a convertible loan available to it.  Pursuant to the Placing, the Company will issue 17,603,759 Shares, raising gross proceeds for the Company of approximately 25.3 million.  A total of 52,210,759 Shares will be in issue immediately following Admission, giving a market capitalisation of approximately 75.2 million at the Placing Price. In addition to the Placing, IP2IPO is providing approximately 4.7 million to the Company by way of a five year, interest-free, unsecured convertible loan, convertible at the Placing Price.

Existing shareholders, IP Group plc (through certain subsidiaries) and Finance Wales plc (through certain funds managed by it), supported the transaction, alongside other UK and international institutional and other investors.

Dr Martin Whitaker, CEO of Diurnal, commented: 

"We are delighted to have been able to complete our IPO successfully.  The new funds will allow us to accelerate the development of our two leading product candidates which are in, or expected to commence shortly, late-stage clinical development targeting diseases of cortisol deficiency; Chronocort®, to be used for Congenital Adrenal Hyperplasia ("CAH") in adults, and Infacort®, to be used for Adrenal Insufficiency ("AI"), including CAH in children.  Our lead product candidate, Infacort®, is anticipated to receive its first regulatory approval in Europe in the third quarter of 2017.

"Our vision is to become the world's leading endocrinology specialty pharma company targeting under-served patient needs in chronic hormonal diseases.  We have identified a number of such needs which we estimate represent a combined market opportunity of more than \\$11 billion.  As potential prescribing endocrinologists for our products are predominantly concentrated in specialist centres throughout Europe and the US, we believe there is significant opportunity, at the right time, to build a cost-effective, focused sales and marketing operation.  This should enable us to maximise the value from our product candidates, once approved, and create a base for further growth through in-licensing.

"We are excited to be entering this new chapter in Diurnal's evolution.  This IPO is a major milestone for the Company which would not have been possible without the hard work of our employees.  We also wish to thank our existing investors for their continuing support and welcome our new shareholders."

Highlights

·      Diurnal is a specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases which the Company believes are currently not met satisfactorily by existing treatments

·      The Company has identified a number of specialist endocrinology market opportunities in Europe and the US that are together estimated to be worth more than \\$11 billion per annum

·      Diurnal's principal product candidates, Infacort® and Chronocort®, are either in, or expected to commence Phase III clinical trials shortly.  Infacort® is currently undergoing a Phase III clinical trial in Europe and Chronocort® is expected to commence a Phase III clinical trial in Europe in Q1 2016

o  These product candidates are initially targeting indications with an estimated global addressable market potential of \\$0.5 billion, rising to \\$3.4 billion with anticipated line extensions in new indications

·      If approved, Infacort® has the potential to be the first licensed treatment in Europe for Adrenal Insufficiency (including Congenital Adrenal Hyperplasia) specifically designed for use in children under six years of age

o  Infacort® is currently in a Phase III clinical trial in Europe; Diurnal anticipates market authorisation in Q3 2017

·      Chronocort® has the potential to be the first product candidate for adults with Congenital Adrenal Hyperplasia to mimic the natural cortisol circadian rhythm, therefore improving disease control

·      Diurnal's products are based on established active pharmaceutical ingredients with no requirement for pre-clinical toxicology and they are therefore associated with a low relative safety risk

·      The target network of prescribers practising in specialist endocrinology centres in Europe and the US is concentrated within specialist centres.  Therefore, the Directors believe that only a modest direct sales and marketing capacity will be required to market its lead product candidates, and that this can be constructed and operated cost-effectively in a financially viable manner

·      Diurnal's lead product candidates have the potential to be granted market and data exclusivity on approval (although this cannot be guaranteed), with Infacort® and Chronocort® benefiting from Orphan Drug Designations in the United States and Chronocort® benefiting from two Orphan Drug Designations in Europe. Diurnal also intends to apply for a paediatric use marketing authorisation for Infacort® in Europe. Diurnal's product candidates also benefit from a number of granted or pending patents in key jurisdictions

·      Diurnal has an experienced board and has built a management team with significant experience in clinical development, regulatory issues and marketing and sales, and will seek to supplement it as its operations mature and new skills and expertise are required

·      Diurnal plans to use its cortisol replacement offering to build a strong platform in under-served diseases of the adrenal gland from which it will expand into disease areas such as those associated with the thyroid, gonads and pituitary

·      Diurnal has realistic opportunities to add further revenue growth over the longer-term via its strong early-stage product pipeline, and is exploring opportunities to in-license or acquire products to sell through its specialist sales force once established