Shield Therapeutics PLC Composition of Matter Patent Granted on Feraccru® (1387J)

TIDMSTX TIDMSTXW

RNS Number : 1387J

Shield Therapeutics PLC

07 September 2016

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO, THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, THE REPUBLIC OF SOUTH AFRICA OR JAPAN OR ANY JURISDICTION WHERE TO DO SO MIGHT CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION

This announcement is an advertisement and not a prospectus. It does not constitute an offer of securities for sale or subscription in any jurisdiction. Investors should not subscribe for or purchase any securities referred to in this announcement except in compliance with applicable securities laws on the basis of information in the Prospectus (the "Prospectus") to be published by Shield Therapeutics plc(1) (the "Company", and as the context may require, together with its subsidiaries and predecessors, "Shield", "Shield Therapeutics" or the "Group") in due course in connection with the offer of its ordinary shares (the "Shares") and the proposed admission of its Shares to the premium listing segment of the Official List of the UK Listing Authority ("UKLA") and to trading on London Stock Exchange plc's (the "London Stock Exchange") main market for listed securities. Copies of the Prospectus will, following publication, be available for inspection, subject to applicable securities laws, from www.shieldtherapeutics.com, and at the Company's main office: Northern Design Centre, Baltic Business Quarter, Gateshead Quays NE8 3DF.

Shield Therapeutics Announces Intention to Float on the

London Stock Exchange's Main Market

London, UK, 7 September 2015. Shield Therapeutics, a specialty pharmaceutical company focused on the development and commercialisation of secondary care-focused pharmaceuticals, today announces its intention to proceed with an Initial Public Offering and fundraising of Shares to certain institutional and other prospective investors (the "Offer") to raise gross proceeds of up to GBP110 million.

Application will be made to the UK Listing Authority and the London Stock Exchange for all of the issued and to be issued Ordinary Shares in the Company to be admitted to the premium segment of the Official List and to trading on the London Stock Exchange's Main Market for listed securities ("Admission"). It is expected that Admission will become effective and that unconditional dealings for normal settlement in the Ordinary Shares will commence on or around 9 October 2015.

Highlights

-- Specialty pharmaceutical company with major market opportunities: Focused on the development and commercialisation of secondary care-focused pharmaceuticals

-- Two late-stage products in development: Feraccru, a novel and effective oral pharmaceutical product for the treatment of iron deficiency anaemia ("IDA") that is currently undergoing a marketing authorisation assessment in Europe; and PT20, a novel phosphate binder that is being developed for the treatment for hyperphosphatemia related to chronic kidney disease ("CKD")

-- Late-stage company with near-term revenue potential: The directors of Shield (the "Directors") expect the company to receive European marketing approval for Feraccru in the first half of 2016 and commence Phase 3 clinical trials of PT20 in 2016

-- Potential for strong cash generation: The Directors anticipate near-term revenues with high gross margins following the expected launch of Feraccru in Europe in 2016 and a relatively modest level of future R&D spend going forward

-- Opportunity to create operational leverage and value via own sales infrastructure: Feraccru and PT20 are intended to be sold directly by the Company using its own central infrastructure and field-based sales representatives and medical science liaisons in the major markets of the EU and in the US

-- Strong intellectual property protection: A suite of strong intellectual property, including key patents in major markets, supports each product. With marketing approval in the EU and US, Feraccru will also benefit from data and marketing exclusivity in the EU and data exclusivity in the US

-- Experienced board and management team: Extensive expertise in the pharmaceutical and biotechnology industry with successful track records of commercialisation and value creation.

Commenting on today's intention to float announcement, Carl Sterritt, CEO of Shield Therapeutics, said: "Shield Therapeutics is at a very exciting stage in its development and this IPO marks another important step in the maturity of the Group as we move from a development focus to one that has revenue generation at its heart. We have a European application for marketing approval of Feraccru currently under review by the European Medicines Agency and have also completed a successful pivotal phase 2b study with PT20. The IDA and hyperphosphatemia markets are both large and growing and we believe each of our late-stage products has the potential to meet a significant unmet need for prescribers and patients. This IPO will raise the additional funds needed to continue the development and commercialisation plans of our key products as we work to build a world-leading independent specialty pharmaceuticals business based in the UK."

Commenting on today's announcement, Dr Andrew Heath, Non-Executive Chairman of Shield Therapeutics, added: "Shield Therapeutics is operating in a large and growing market with pharmaceutical products in late-stage development that have the potential to make a meaningful impact on society. Shield's Board and executive management team has a strong track record in both commercialising pharmaceuticals and creating value for shareholders. We look forward to joining other highly respected pharmaceutical peers on the London Stock Exchange."

Overview of the Offer

   --     The Offer will comprise new Shares to be issued by the Company 
   --     The Company anticipates raising gross proceeds of up to GBP110 million 

-- The Company's clear objective is to use its existing cash balances and the net proceeds from the Offer to continue the development and commercialisation programmes of both Feraccru and PT20 to a stage where they will generate significant revenues

-- Certain existing institutional shareholders will be subject to lock-up arrangements on existing holdings for 180 days following completion of the Offer

-- The Directors and Management will be subject to lock-up arrangements for 365 days following completion of the Offer

-- Under the Offer, the Shares will be offered (i) to certain institutional investors in the United Kingdom and elsewhere outside the United States in reliance on Regulation S under the US Securities Act of 1933, as amended (the "Securities Act") and in accordance with locally applicable laws and regulations; and (ii) in the United States only to investors that are both "Qualified Institutional Buyers" as defined in Rule 144A under the Securities Act and "Major US Institutional Investors" as defined in Rule 15a-6 under the US Securities Exchange Act of 1934, as amended, pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act.

-- In relation to the Offer, Investec Bank plc ("Investec") and Canaccord Genuity Limited ("Canaccord") are acting jointly as sponsors and Investec, Canaccord and RBC Capital Markets ("RBC") are acting jointly as bookrunners for the Company.

For further information please contact:

 
 Shield Therapeutics                               [phone] 
 Carl Sterritt, Chief 
  Executive Officer 
  Richard Jones, Chief 
  Financial Officer 
 
 Financial PR Advisor                              [phone] 
  Consilium Strategic           [e-mail] 
  Communications 
 Mary-Jane Elliott 
  Matthew Neal 
  Lindsey Neville 
  Hendrik Thys 
 
 Joint Sponsors and 
  Joint Bookrunners 
  Investec Bank 
  Daniel Adams 
  Patrick Robb 
  Matt Lewis                                       [phone] 
 
 Joint Sponsors and 
  Joint Bookrunners 
  Canaccord Genuity 
  Dr Julian Feneley 
  Henry Fitzgerald-O'Connor 
  Guillaume Arnaldez                               [phone] 
 
 Joint Bookrunner 
  RBC Capital Markets 
  Paul Tomasic 
  Thomas Stockman 
  Rupert Walford                                   [phone] 
 
 

About Shield Therapeutics

Overview

Shield Therapeutics is a specialty pharmaceutical company focused on the development and commercialisation of secondary care-focused pharmaceuticals. The Company's lead products are Feraccru and PT20.

Feraccru

Feraccru is a novel, effective, ferric iron-based, oral pharmaceutical product that, if approved, is anticipated to initially be licensed to treat Iron Deficiency Anaemia ("IDA") in patients who are not able to tolerate oral ferrous products, or for whom such treatments are not suitable; and in patients with inflammatory bowel disease ("IBD").

Feraccru market opportunity

There is a large and attractive market of patients with IDA whose only current option is intravenous iron therapy as currently available oral treatments demonstrate limited effectiveness due to negative adverse event profiles leading to low levels of compliance. Intravenous therapies also have limitations as they are expensive to administer, require time-consuming and inconvenient intermittent administration and, due to their potential to cause life-threatening hypersensitivity reactions, are required to be administered in a healthcare facility where resuscitation facilities are available.

Feraccru addresses a large and growing market, with significant near-term potential. GfK UK Limited ("GfK"), an established independent market research company, estimates that there are approximately 1.4 to 1.5 million patients in Europe and the US with IBD who have the potential to be treated for IDA(2) , of which a significant proportion are currently either not treated or ineffectively treated. GfK also estimates that there are more than 3.4 million patients in the EU and US with IDA and CKD(2) , Shield's second target indication for Feraccru. In the longer term, Feraccru has the potential to expand into a number of additional indications and geographies, thus significantly expanding the potential number of patients available for treatment.

In addition, during the life of the patent families relating to Feraccru, the Directors believe there is potential for Feraccru to be established in the primary care setting where there are a significant number of potential patients, particularly in treatment of IDA in women's health and treatment of IDA in the elderly population.

Feraccru clinical data

To date, clinical studies of Feraccru in IDA patients intolerant of other oral iron therapies have demonstrated the potential for it to be an effective daily oral treatment in such patients, so providing an alternative to intravenous iron. The most significant study conducted was the Group's pivotal Phase 3 Study that completed in 2014, meeting the primary and all secondary endpoints of efficacy and safety. The Company is now conducting a study of Feraccru comparing it directly to the leading IV iron product, Ferinject, with initial data expected in the second half of 2016. The Company also plans to conduct further studies to generate pivotal data in other indications where the Directors believe IDA is a significant problem, firstly in CKD, but also including women's health, chronic heart failure, surgery and oncology and to provide additional safety data to enable the Company to expand its regulatory approvals initially into the US and then potentially into other geographies and indications. The Directors anticipate receiving Marketing Authorisation ("MA") approval for Feraccru in the first half of 2016.

PT20

PT20 is a novel iron-based phosphate binder being developed for the treatment of hyperphosphatemia related to CKD. PT20 is an effective, safe and well-tolerated phosphate binder and importantly, in this patient population, early studies have indicated it will have the ability to be used with a relatively low pill burden.

PT20 was invented in the UK by leading Cambridge-based scientists and is exclusively licensed from the Medical Research Council (the "MRC"). Patients with late-stage renal disease suffer from hyperphosphatemia, which enhances the risk of vascular calcification, leading to increased morbidity and mortality. Without phosphate binder medication low phosphate diets and regular dialysis sessions are by themselves unable to prevent gradual phosphate accumulation, therefore oral phosphate binders are routinely used to reduce absorption of phosphate and thereby reduce blood phosphate levels. The Directors believe there is a large and attractive commercial market for PT20 as current treatments are often limited by at least one of the following problems: limited therapeutic dosing range, low specificity, high pill loading, gastrointestinal side effects, calcium loading or significant toxicity concerns.

PT20 market opportunity

The hyperphosphatemia market is large and growing. GfK estimates that there are more than 650,000 patients in the EU and US on dialysis, the majority of whom are currently being treated with phosphate binders(2) , yet current therapies for the treatment of hyperphosphatemia only have a moderate degree of satisfaction(2) . In addition there is a large population of pre-dialysis CKD patients who are much less likely to receive treatment for hyperphosphataemia as the prescribing guidelines vary between Europe and the US for the leading phosphate binders, i.e. there are no phosphate binders approved for use in pre-dialysis CKD patients in the US, representing a very large potential market for a novel, safe and effective phosphate binder.

PT20 clinical data

To date, studies conducted by the Group have demonstrated the potential of PT20 to deliver an effective treatment for hyperphosphatemia related to dialysis dependent CKD. The Group successfully completed a pivotal Phase 2 clinical trial in 2015 and has commenced planning for the Phase 3 development of PT20, the clinical trials for which are due to start in 2016.

Competitive landscape for Shield Therapeutics' late-stage products

There are a number of established companies engaged in the development and marketing of intravenous iron-based preparations addressing the IDA market and in particular, in patients intolerant of existing oral products. In addition, there is a wide range of currently approved and marketed oral ferrous-based products attempting to address the IDA market. As it is intended that Feraccru will be targeted initially as a treatment for IDA in patients intolerant of existing oral iron-based products and the pivotal phase 3 data on Feraccru has been collected in such patients, the Directors do not regard current oral ferrous products as direct competitors, and accordingly intravenous iron is regarded by the Directors as being Feraccru's main competitor.

In respect of PT20, there are a number of current marketed products seeking to address the market for hyperphosphatemia and a number of additional products in development. Certain competitor products have reached or are due to reach the end of their patent life in the foreseeable future and therefore further generic competition is anticipated in this market, particularly in the US. The key issues in the current competitive market include, inter alia, the high pill burden inherent in current binders, the less than satisfactory therapies for the treatment of hyperphosphatemia and the high incidence of side effects.

Company reorganisation

In preparation for Admission, the Group is undertaking a Corporate Reorganisation that will result in Shield Therapeutics becoming the ultimate holding company of the Group. Upon Admission, the Company will have two directly held, wholly owned subsidiaries, Shield Holdings AG ("SHG") and Phosphate Therapeutics Limited ("PTL").

SHG is focused on the development and commercialisation of Feraccru. SHG will have one wholly owned subsidiary, Iron Therapeutics Holdings AG ("ITH"). ITH owns the intellectual property related to Feraccru and has two wholly owned subsidiaries, Iron Therapeutics (Switzerland) AG ("ITS") and Iron Therapeutics (UK) Limited ("ITU"). ITS and ITU are the main trading companies of the SHG Group which have been conducting the Group's clinical trials and which employ the Group's staff.

PTL is focused on PT20 and owns the licences in respect of certain patent rights and related know-how to develop and commercialise products for specific medical applications, including in relation to PT20.

Key strengths of the Group

Near-term revenue potential

The European application for a marketing authorisation (MA) of Feraccru was filed in December 2014 and, if approval is forthcoming, the Company is planning to launch Feraccru in Europe in 2016, thus providing the potential for near term revenues.

Company with late stage products heading towards commercialisation

In addition to Feraccru's MAA being under review by the European Medicines Authority, the Phase 2b pivotal study of PT20 has completed.

Large market opportunities with unmet needs

Feraccru addresses a large and growing market with significant potential in the near term and for PT20 the hyperphosphatemia market is also large and growing.

Experienced board combined with a management team with extensive expertise

The Company has an experienced Board with a strong track record of value creation for shareholders and successful commercialisation of pharmaceutical products. The Board is supported by a skilled and experienced management team that also has a successful track record covering all major aspects of pharmaceutical development and commercialisation. Together these provide a platform for future growth by giving clear strategic direction to the development and commercialisation of the Group's products.

Opportunity to create operational leverage

In the major markets of the EU and in the US Feraccru and PT20 are each intended to be sold directly by the Company using its own central infrastructure and field-based sales representatives and medical science liaisons. If approved, the Company plans to primarily target specialist prescribers based in hospitals and private clinics. The Directors believe this will provide the potential for operational leverage, which could be enhanced with selective small-scale bolt-on acquisitions or in-licensing of allied products.

Strong intellectual property protection

Both Feraccru and PT20 are each supported by a suite of strong intellectual property, including key patents in major markets. With Marketing Authorisation and New Drug Application approvals, Feraccru will also benefit from data and marketing exclusivity in the EU (up to 10 years) and data exclusivity in the US (up to 3 years). The Company has been actively pursuing new patent applications and has filed 5 new patent applications for Feraccru since SHG's acquisition of Feraccru and all of its then existing intellectual property from Vitra Pharmaceuticals in 2010. The new patents related to Feraccru, if granted, should provide significant additional patent protection up to 2035.

Attractive financial profile

From 2016 onwards, following the planned launch of Feraccru in Europe, the Directors expect the Company to generate revenues with high gross margins. Whilst development activity will continue for the foreseeable future, the Directors believe that the level of R&D spend should be relatively modest compared to normal industry levels, having regard to the potential revenues from Feraccru and PT20. These two points provide a robust basis for strong cash generating potential in the future.

Key financials

Pursuant to the Corporate Reorganisation detailed above, the Company will upon Admission become the holding company of Shield Holdings AG (and its subsidiaries) within which the intellectual property relating to Feraccru is held and Phosphate Therapeutics Limited which holds the PT20 asset. Accordingly, set out below is certain unaudited historical financial information on each of the separate SHG and PTL entities.

Shield Holdings

Consolidated Statement of Profit and loss and Other Comprehensive Income

 
 
                                       Year           Year           Year 
                                       ended          ended          ended 
                                       31 December    31 December    31 December 
                                       2012           2013           2014 
                                     GBP000         GBP000         GBP000 
 
Other operating income               203            244            244 
Research and development 
 expenditure                         (3,370)        (3,123)        (2,859) 
Administrative expenses              (438)          (963)          (776) 
 
Operating loss                       (3,605)        (3,842)        (3,391) 
Financial income                     650            591            206 
Net loss on financial instruments 
 designated as fair value through 
 profit or loss                      -              -              (8,585) 
Financial expense                    (505)          (1,266)        (1,660) 
 
Loss before tax                      (3,460)        (4,517)        (13,430) 
Taxation                             -              -              - 
 
Loss for the period                  (3,460)        (4,517)        (13,430) 
 
 
  Attributable to: 
Equity holders of the parent         (3,147)        (4,189)        (12,905) 
Non-controlling interests            (313)          (328)          (525) 
 
 
 
  Other comprehensive income 
Items that are or may be 
 reclassified subsequently 
 to profit or loss: 
Foreign currency translation 
 differences - foreign operations    (71)           41             248 
 
Total comprehensive income 
 for the period                      (3,531)        (4,476)        (13,182) 
 
Attributable to: 
Equity holders of the parent         (3,218)        (4,148)        (12,657) 
Non-controlling interests            (313)          (328)          (525) 
 
Basic loss per share                 (6.8p)         (8.9p)         (26.5p) 
 
Diluted loss per share               (6.8p)         (8.9p)         (26.5p) 
 
 

Shield Holdings

Consolidated balance sheet

 
 
                                   31 December    31 December    31 December 
                                   2012           2013           2014 
                                 GBP000         GBP000         GBP000 
 
Non-current assets 
Intangible assets                321            387            436 
Property, plant and equipment    5              5              12 
 
                                 326            392            448 
Current assets 
Other receivables                124            101            79 
Cash and cash equivalents        4,004          1,550          477 
 
                                 4,128          1,651          556 
 
Total assets                     4,454          2,043          1,004 
 
Current liabilities 
Trade and other payables         (903)          (919)          (694) 
Interest bearing loans 
 and borrowings                  (4,843)        (7,093)        (8,258) 
Other liabilities                (80)           (36)           (50) 
 
                                 (5,826)        (8,048)        (9,002) 
 
Non-current liabilities 
Interest bearing loans 
 and borrowings                  -              -              (197) 
Other financial liabilities      (1,871)        (1,312)        (10,089) 
 
                                 (1,871)        (1,312)        (10,286) 
 
Total liabilities                (7,697)        (9,360)        (19,288) 
 
Net liabilities                  (3,243)        (7,317)        (18,284) 
 
Equity 
Share capital                    365            365            365 
Share premium                    2,393          2,393          2,393 
Currency translation reserve     (71)           (30)           218 
Retained earnings                (7,005)        (10,792)       (23,006) 
 
Equity attributable to 
 owners of the parent            (4,318)        (8,064)        (20,030) 
Non-controlling interest         1,075          747            1,746 
 
Total equity                     (3,243)        (7,317)        (18,284) 
 
 

Phosphate Therapeutics Limited

Income statement

 
 
                              Year           Year           Year 
                              ended          ended          ended 
                              31 December    31 December    31 December 
                              2012           2013           2014 
                            GBP000         GBP000         GBP000 
 
Research and development 
 expenditure                (513)          (1,647)        (2,810) 
Administrative expenses     (203)          (106)          (207) 
 
Operating loss              (716)          (1,753)        (3,017) 
Financial income            11             4              - 
Financial expense           (680)          (767)          (1,700) 
 
Loss before tax             (1,385)        (2,516)        (4,717) 
Taxation                    19             286            (280) 
 
Loss for the period         (1,366)        (2,230)        (4,997) 
 
 

All activities relate to continuing operations.

Phosphate Therapeutics Limited

Statement of other comprehensive income

 
 
                         Year           Year           Year 
                         ended          ended          ended 
                         31 December    31 December    31 December 
                         2012           2013           2014 
                       GBP000         GBP000         GBP000 
 
Loss for the period    (1,366)        (2,230)        (4,997) 
 
 

Phosphate Therapeutics Limited

Balance sheet

 
 
                                 Year           Year           Year 
                                 ended          ended          ended 
                                 31 December    31 December    31 December 
                                 2012           2013           2014 
                               GBP000         GBP000         GBP000 
 
Non-current assets 
Intangible assets              806            865            846 
 
 
Current assets 
Trade and other receivables    244            166            206 
Other financial assets         -              -              1,563 
Cash and cash equivalents      2,445          1,331          6 
Tax receivable                 19             306            - 
 
                               2,708          1,803          1,775 
 
Total assets                   3,514          2,668          2,621 
 
Current liabilities 
Trade and other payables       (177)          (651)          (860) 
Interest bearing loans 
 and borrowings                (4,702)        (5,612)        (10,353) 
 
Total liabilities              (4,879)        (6,263)        (11,213) 
 
Net liabilities                (1,365)        (3,595)        (8,592) 
 
Equity 
Share capital                  1              1              1 
Retained earnings              (1,366)        (3,596)        (8,593) 
 
Total equity                   (1,365)        (3,595)        (8,592) 
 
 

Established manufacturing partners

Feraccru is currently manufactured on behalf of the Company by Piramal Healthcare UK Limited ("Piramal"), a leading provider of clinical services and commercial manufacturing to the global pharmaceutical industry. The Group has been working with Piramal since 2010. Piramal has been contracted to produce sufficient commercial batches of Feraccru in time for planned launch.

Reasons for the Offer

The Company intends to use its existing cash balances and net proceeds from the Offer with the clear objective of bringing both Feraccru and PT20 to a stage where they can generate significant revenues. The net proceeds from the Offer are intended to be applied as follows:

-- Continue to develop Feraccru by conducting further clinical trials to support commercial plans by facilitating further regulatory approvals in the US and other markets and in other indications

-- Continue to develop PT20, including a planned pivotal Phase 3 programme, and subsequently to seek marketing approval for PT20 in Europe and the US

   --     Fund other regulatory and manufacturing costs 
   --     Prepare for the launch of Feraccru in European markets and subsequently in the US market 
   --     Fund necessary expansion of the Group's central infrastructure 
   --     Buy-out historic Feraccru royalty arrangements with Vitra Pharmaceuticals 

Board and corporate governance

The Company has an experienced Board with extensive expertise in the pharmaceutical and biotechnology industry. On Admission, the Board is expected to comprise of the following:

   --     Non-Executive Chairman: Dr Andrew Heath 
   --     Chief Executive Officer: Carl Sterritt 
   --     Chief Financial Officer and Company Secretary: Richard Jones 
   --     Non-Executive Director: Dr Lynn Drummond 
   --     Non-Executive Director: James Karis 

There is an intention to appoint another Non-Executive Director and the Group is in discussions with potential candidates and will make an announcement on an appointment as soon as practicable after Admission. W Health L.P., an existing major institutional investor will be entitled to and is expected to nominate one Non-Executive Director for appointment to the Board on or before Admission. Biographical details for the nominee will be set out in the Prospectus.

NOTES FOR EDITORS

Board Biographies

Dr Andrew Heath (Non-Executive Chairman) - Dr Andrew Heath is a highly experienced healthcare and biopharmaceutical executive with in-depth knowledge of US and UK capital markets and international experience in marketing, sales, R&D and business development. Dr Heath is currently Deputy Chairman and Senior Independent Director of Oxford BioMedica plc and is a non-executive director of Novacyt SA, IHT LLC and Anew Inc. Dr Heath was formerly a director of the BioIndustry Association and he was Chief Executive Officer of Protherics plc from 1999 to 2008, taking the company from 30 to 350 staff and managing its eventual acquisition by BTG for GBP220 million. Prior to this Andrew served as Vice President of Marketing and Sales, for Astra Inc in the U.S. and also held senior positions at Glaxo Sweden.

Carl Sterritt (Chief Executive Officer) - With 20 years' of management and executive level experience in pharmaceutical development and commercialisation in both large and small company settings, Carl has led the Group as its CEO since he co-founded SHG in 2008 and PTL in 2011. Previously, Carl held senior management roles at United Therapeutics and Encysive Pharmaceuticals, working on innovative therapies for the treatment of pulmonary arterial hypertension. Carl joined United Therapeutics to establish the company's European operations in preparation for the marketing approval of Remodulin, subsequently running the subsidiary for six years. In collaboration with physicians in Germany, he was responsible for and holds patents related to United Therapeutics' decision to develop and commercialise an inhaled version of treprostinil; now successfully commercialised in the US as Tyvaso. Carl was instrumental in the successful commercial launch of Thelin in Europe and the rapid growth of Encysive's European operations. Carl founded SHG after Pfizer Inc. acquired Encysive for more than $300m.

Richard Jones, ACA (Chief Financial Officer and Company Secretary) - Richard was appointed a Non-Executive Director of SHG in early 2010 and Chief Financial Officer in April 2011. Richard has advised the Group since its inception in his previous role as an investment banker with both Brewin Dolphin Securities and Investec. Richard has a strong track record in advising clients on a wide range of transactions and fundraisings including IPOs, M&A and fundraisings. With more than 10 years' advisory experience in the investment banking industry, his particular focus was in the healthcare sector where he developed extensive experience with a broad range of clients including private companies, private equity and UK and European quoted companies. Richard qualified as a Chartered Accountant with PwC in 1991.

Dr Lynn Drummond (Non-Executive Director) - Lynn has a strong track record within life sciences, bringing over twenty five years of management and advisory experience to the sector. Lynn spent 16 years at N.M. Rothschild in London most recently as a Managing Director within the investment banking division, with a particular focus on transactions within the healthcare sector. Prior to this she worked in the Cabinet Office in London as Private Secretary to the Chief Scientific Advisor. She spent the early part of her career as a research scientist, including a year in Tokyo, Japan as a post-doctoral research fellow. Lynn joined the board of directors of SHG in 2013 and has provided valuable input into the development of Feraccru and the strategic direction of SHG. She is currently also Non-Executive Chairman of Infirst Healthcare and Venture Life Group plc and is a Non-Executive Director of RPC Group plc. Dr Drummond holds a Bachelor of Science Degree in Chemistry from the University of Glasgow and a PhD in Biochemistry from the University of London. She is a Fellow of the Royal Society of Edinburgh and a Fellow of the Royal Society of Chemistry.

James Karis (Non-Executive Director) - James is a life sciences and healthcare industry executive with over 35 years of experience in the pharmaceutical, healthcare services, technology and medical device industries. A proven entrepreneur he is also an experienced Board member for public and private companies with extensive experience in corporate strategy, M&A and all aspects of company financing. He is currently Chief Executive Officer of privately held Mapi Group, a company focused on conducting late phase studies as well as providing regulatory and reimbursement support to the pharmaceutical and device Industries. James has previously held senior management and executive roles at CollabRx, Entelos, Inc., PAREXEL International, Pharmaco International and Baxter International. He has a B.S. in Management and Economics from Purdue University and a M.A. in Applied Economics from The American University.

References

(1) Pursuant to the Corporate Reorganisation, Shield Therapeutics plc will, upon Admission, become the ultimate holding company of the Group with two directly held, wholly owned subsidiaries, Shield Holdings AG and Phosphate Therapeutics Limited

(2) GfK UK Limited estimates based on market and industry data research undertaken by GfK, which will be set out in the Prospectus in a report prepared by GfK.

Forward-looking statements

This announcement contains "forward-looking" statement, beliefs or opinions. These forward-looking statements involve known and unknown risks and uncertainties, many of which are beyond the control of Shield and all of which are based on the Directors' current beliefs and expectations about future events. Forward-looking statements are sometimes identified by the use of forward-looking terminology such as "believes", "expects", "may", "will", "could", "should", "shall", "risk", "intends", "estimates", "aims", "plans", "predicts", "projects", "continues", "assumes", "positioned" or "anticipates" or the negative thereof, other variations thereon or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events, assumptions or intentions. These forward-looking statements include all matters that are not historical facts. Forward-looking statements may and often do differ materially from actual results. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors or Shield with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Company's business concerning, amongst other things, the results of operations, financial condition, liquidity, prospects, growth and strategies of Shield and the industry in which it operates. These forward-looking statements and other statements contained in this announcement regarding matters that are not historical facts involve predictions. No assurance can be given that such future results will be achieved; actual events or results may differ materially as a result of risks and uncertainties facing Shield. Such risks and uncertainties could cause actual results to vary materially from the future results indicated, expressed or implied in such forward-looking statements. The forward-looking statements contained in this announcement speak only as of the date of this announcement. Nothing in this announcement is, or should be relied on as, a promise or representation as to the future. The Company disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in its expectations or any change in events, conditions or circumstances on which such statements are based unless required to do so by applicable law, the Prospectus Rules, the Listing Rules or the Disclosure Rules and Transparency Rules of the Financial Conduct Authority (the "FCA"). No statement in this announcement is intended as a profit forecast or profit estimate.

Each of Investec, Canaccord and RBC and their respective affiliates expressly disclaims any obligation or undertaking to update, review or revise any forward-looking statements contained in this announcement whether as a result of new information, future developments or otherwise.

Important notice

The contents of this announcement, which have been prepared by and are the sole responsibility of Shield, have been approved by Investec solely for the purposes of section 21(2)(b) of the Financial Services and Markets Act 2000.

Important information

Neither this announcement nor any copy of it may be made or transmitted into the United States of America (including its territories or possessions, any state of the United States of America and the District of Columbia) (the "United States"), or distributed, directly or indirectly, in the United States. Neither this announcement nor any copy of it may be taken or transmitted directly or indirectly into Australia, Canada or Japan or to any persons in any of those jurisdictions, except in compliance with applicable securities laws. Any failure to comply with this restriction may constitute a violation of United States, Australian, Canadian or Japanese securities laws. The distribution of this announcement in other jurisdictions may be restricted by law and persons into whose possession this announcement comes should inform themselves about, and observe, any such restrictions. This announcement does not constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for securities in the United States, Australia, Canada or Japan or in any

jurisdiction to whom or in which such offer or solicitation is unlawful.

The securities to which this announcement relates have not been, and will not be, registered under the US Securities Act of 1933, as amended (the "Securities Act") or with any regulatory authority or under any applicable securities laws of any state or other jurisdiction of the United States, and may not be offered or sold within the United States unless registered under the Securities Act or pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with applicable state laws. There will be no public offer of the securities in the United States.

The securities referred to herein have not been registered under the applicable securities laws of Australia, Canada or Japan and, subject to certain exceptions, may not be offered or sold within Australia, Canada or Japan or to any national, resident or citizen of Australia, Canada or Japan.

The securities to which this announcement relates have not been approved or disapproved by the U.S. Securities and Exchange Commission, any state securities commission in the United States or any United States regulatory authority, nor have any of the foregoing authorities passed upon or endorsed the merits of the offering of the securities or the accuracy of adequacy of this announcement. Any representation to the contrary is a criminal offence in the United States.

In any EEA Member State that has implemented Directive 2003/71/EC, as amended including by Directive 2010/73/EU (together with any applicable implementing measures in any Member State, the "Prospectus Directive"), this announcement is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive.

This announcement is an advertisement and not a prospectus. Investors should not subscribe for or purchase any securities referred to in this announcement except in compliance with applicable securities laws on the basis of information in the Prospectus intended to be published by Shield in due course in connection with the offer of its Shares and the proposed admission of its Shares to the premium listing segment of the Official List and to trading on the Main Market of the London Stock Exchange. Copies of the Prospectus will, following publication, be available, subject to applicable securities laws, from www.shieldtherapeutics.com and at the Company's main office at: Northern Design Centre, Baltic Business Quarter, Gateshead Quays NE8 3DF.

Any purchase of Shares in the proposed Offer should be made solely on the basis of the information contained in the final Prospectus to be issued by the Company in connection with the Offer, which will contain detailed information about the Company and its management, as well as financial statements. Before purchasing any Shares, persons viewing this announcement should ensure that they fully understand and accept the risks, which will be set out in the Prospectus when published. The information in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness. This announcement does not constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for any Shares or any other securities nor shall it (or any part of it) or the fact of its distribution, form the basis of, or be relied on in connection with, any contract therefor.

This announcement does not constitute a recommendation concerning the Offer. The price and value of securities and any income from them can go down as well as up. Past performance is not a guide to future performance. Before purchasing any Shares, persons viewing this announcement should ensure that they fully understand and accept the risks that will be set out in the Prospectus, when published. Information in this announcement or any of the documents relating to the Offer cannot be relied upon as a guide to future performance. There is no guarantee that Admission will occur and you should not base your financial decisions on Shield's intentions in relation to Admission at this stage. Potential investors should consult a professional advisor as to the suitability of the Offer for the entity concerned.

Each of Investec and RBC is authorised by the UK Prudential Regulation Authority (the "PRA") and regulated by the PRA and the FCA in the United Kingdom. Canaccord is authorised and regulated by the FCA in the United Kingdom. Each of Investec, Canaccord and RBC is acting exclusively for the Company and no one else in connection with the Offer and will not regard any other person as a client in relation to the Offer and will not be responsible to anyone other than the Company for providing the protections afforded to their respective clients nor for giving advice in relation to the Offer or any transaction, matter or arrangement referred to in this announcement.

In connection with the Offer, each of Investec, Canaccord and RBC and any of their respective affiliates, acting as investors for their own accounts, may subscribe for or purchase Shares and in that capacity may retain, purchase, sell, offer to sell or otherwise deal for their own accounts in such Shares and other securities of Shield or related investments in connection with the Offer or otherwise. Accordingly, references in the Prospectus, once published, to the Shares being issued, offered, subscribed, acquired, placed or otherwise dealt in should be read as including any issue or offer to, or subscription, acquisition, placing or dealing by, Investec, Canaccord and RBC or any of their respective affiliates acting as investors for their own accounts. Investec, Canaccord and RBC and their respective affiliates do not intend to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligations to do so.

Apart from the responsibilities and liabilities, if any, which may be imposed on any of Investec, Canaccord and RBC by the Financial Services and Markets Act 2000 or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, none of Investec, Canaccord and RBC or any of their respective affiliates accepts any responsibility whatsoever for, or makes any representation or warranty, express or implied, as to the contents of this announcement or for any other statement made or purported to be made by it, or on its behalf, in connection with the Company, the Shares or the Offer and nothing in this announcement will be relied upon as a promise or representation in this respect, whether or not to the past or future. Each of Investec, Canaccord and RBC and their respective affiliates accordingly disclaims all and any responsibility or liability, whether arising in tort, contract or otherwise (save as referred to above) in respect of this announcement or any such statement.

Certain figures contained in this announcement, including financial information, have been subject to rounding adjustments. Accordingly, in certain instances, the sum or percentage change of the numbers contained in this announcement may not conform exactly to the total figure given.

This information is provided by RNS

The company news service from the London Stock Exchange

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September 07, 2016 02:01 ET (06:01 GMT)