Shield Thera Regulatory News (STX)

Shield Therapeutics plc

("Shield" or the "Group")

Appointment of Chairman 

London, UK, 22 January 2019: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company with an initial focus on addressing iron deficiency, is pleased to announce the appointment of James Karis as non-executive Chairman of the Company with immediate effect.

James has served on Shield's Board of Directors for almost 3 years as a member of the Audit and Nominations Committees and as Chair of the Remuneration Committee. A proven entrepreneur, he brings to Shield over 35 years of experience in the pharmaceutical, healthcare services, technology and medical device industries. He is also a seasoned Board member for both public and private companies with extensive experience in corporate strategy, M&A and all aspects of company financing, particularly with respect to the US market. Most recently he was Chief Executive Officer of the privately held MAPI Group until its sale to ICON plc in 2018 and has previously held senior management and executive roles at CollabRx, Entelos, Inc., PAREXEL International, Pharmaco International and Baxter International.

James Karis, Chairman of Shield Therapeutics, said: "It is exciting to take on an expanded role as Chairman of Shield Therapeutics during a time when the Company has several important milestones on the horizon. I look forward to working with the rest of the Board and management team in continuing our efforts to provide a unique therapy benefiting patients around the world while making Shield a success for its shareholders."

Carl Sterritt, CEO of Shield Therapeutics, said: "I am very pleased to see James appointed as our Chair. The understanding of the business and the opportunity for Feraccru that he has developed over the last three years of Shield Therapeutics, combined with his extensive leadership experience and multiple exposures to licensing, mergers and acquisitions, not least in the USA, will, I am sure, prove to be of significant value to Shield's shareholders. I look forward to working closely with and benefitting from his counsel as we look to execute on our strategy to crystallise the significant value that exists in our excellent product portfolio."

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For further information please contact:

Shield Therapeutics plc +44 (0)207 186 8500

Carl Sterritt, Chief Executive Officer

Tim Watts, Chief Financial Officer

Nominated Advisor and Joint Broker +44 (0)203 100 2222

Liberum Capital Limited

Christopher Britton/Steve Pearce

Joint Broker +44 (0)207 418 8900

Peel Hunt LLP

James Steel/ Dr Christopher Golden

Financial PR +44 (0)203 709 5700

Consilium Strategic Communications

Mary-Jane Elliott/Matthew Neal

About Feraccru®

Feraccru® is a novel, stable, non-salt, oral formulation of ferric iron, which has a differentiated mechanism of absorption compared to salt-based oral iron therapies. When salt-based oral iron therapies are ingested, the iron must dissociate from the salt in the GI tract to allow the iron to be absorbed and treat the IDA. This free iron readily chelates to form insoluble clumps and produces damaging free radicals that together cause a range of mild-to-severe GI adverse events, including nausea, bloating and constipation, leading to poor tolerability, reduced patient compliance and ultimately treatment failure. In addition, many patients with IDA are concurrently treated with medicines that raise the pH in the gut which further reduces the effect of salt-based oral iron therapies as they require highly acidic conditions to be absorbed.

Feraccru® is not an iron salt, and iron can be absorbed from the ferric maltol molecule, and as a result, it does not routinely cause the same treatment-limiting intolerance issues. Feraccru® has been shown in clinical trials to be well-tolerated by patients even when they had previously failed treatment with salt-based oral iron therapies, which should lead to increased patient compliance and better patient outcomes.

Currently, the only treatment option for IDA patients who cannot tolerate salt-based oral iron therapies, is IV iron therapy. IV iron therapies quickly increase iron stores via direct administration of very large doses of iron, causing an increase in Hb levels that is physiologically controlled and occurs over a period of weeks, as is the case with Feraccru®. IV iron therapies, however, are invasive, costly, inconvenient and complex to administer, and also come with potentially life-threatening, spontaneous hypersensitivity reactions.

About Shield Therapeutics plc

Shield is a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs. Our clear purpose is to help our patients become people again, by enabling them to enjoy the things that make the difference in their everyday lives. The Group has a marketed product, Feraccru®, for the treatment of iron deficiency in adult patients with or without anaemia. Feraccru® has exclusive IP rights until the mid-2030's. For more information please visit www.shieldtherapeutics.com. 

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management's current expectations and include statements related to the timing of future results of Feraccru trials and the timing and success of the Group's regulatory plans and commercial strategy for Feraccru. These statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties, many of which are beyond our control, that may cause actual results, performance or achievements to be materially different from management's expectations expressed or implied by the forward-looking statements, including, but not limited to, risks associated with the regulatory approval process, the Group's business and results of operations, competition and other market factors. The forward-looking statements made in this press release represent management's expectations as of the date of this press release, and except as required by law, the Group disclaims any obligation to update any forward-looking statements contained in this release, even if subsequent events cause our views to change.