Shield Thera Regulatory News (STX)

Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

Licence Agreement in Canada for Accrufer®

Exclusive licence agreement with KYE Pharmaceuticals Inc. for development and commercialisation of Accrufer®

Deal Highlights:

· Up to £1 million in upfront, development and sales milestones

· Double-digit royalties on net sales

· KYE Pharmaceuticals Inc. to be responsible for, and cover costs of all development and regulatory activity

London, UK, 5 January, 2022: Shield Therapeutics plc (LSE: STX), a commercial stage specialty pharmaceutical company with a focus on addressing iron deficiency with its lead product Accrufer®/Feraccru® (ferric maltol), announces that it has entered into an exclusive licence agreement ("the Agreement") for Accrufer® with KYE Pharmaceuticals Inc. ("KYE") in Canada. KYE will undertake and be responsible for all costs, both clinical and regulatory, related to activities required to achieve marketing authorisation and commercialisation of Accrufer® in Canada. Shield will be responsible for all manufacturing costs of goods sold in Canada.

Shield will receive an upfront payment of £150,000 and is eligible to receive £850,000 in development and sales milestones comprised of a payment of £250,000 upon regulatory approval of Accrufer® by Health Canada and up to £600,000 in milestone payments upon the achievement of specified calendar net sales targets. For the term of the agreement, Shield will also receive double-digit royalties on net sales of Accrufer®.

Greg Madison, Chief Executive Officer for Shield, said: "This Agreement for the development and commercialisation of Accrufer® in Canada gets 2022 off to a great start for Shield. We are dedicated to growing sales of Accrufer®/Feraccru® and bringing this important product to patients around the world with iron deficiency. Securing a commercial partnership for Canada is an important part of our strategy and we feel that KYE is the right partner. We look forward to supporting KYE's efforts to bring Accrufer® to the market in Canada.

"Shield has made significant progress on the commercial launch of Accrufer®/Feraccru® over the last 12 months by implementing important geographic partnerships and successfully securing payer coverage with several large pharmacy benefit managers. We look forward to continuing to expand the awareness of Accrufer®/Feraccru® among healthcare professionals in 2022."

Doug Reynolds, President of KYE, commented: "Iron deficiency is highly prevalent worldwide and a public health concern in Canada. Accrufer® will be the first oral prescription only therapy available in Canada to treat patients who continue to suffer from low iron despite attempts at treatment with currently available agents. This agreement is very much aligned with our strategy to bring innovative medicines to the people of Canada and KYE is proud to be partnering with Shield. We look forward to bringing Accrufer® to the Canadian market in the near future."

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About Shield Therapeutics plc

Shield is a commercial stage specialty pharmaceutical company with a focus on addressing iron deficiency with its lead product Accrufer®/Feraccru® (ferric maltol), a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia.

Shield's lead product, Accrufer®/Feraccru®, has been approved for use in the United States, European Union, UK, Switzerland, and Australia and has exclusive IP rights until the mid-2030s. The Group has recently launched Accrufer® in the US. Feraccru® is being commercialised in the UK and European Union by Norgine B.V., who also have the marketing rights in Australia and New Zealand. Shield also has an exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialisation of Accrufer®/Feraccru® in China, Hong Kong, Macau, and Taiwan, and with Korea Pharma Co., Ltd. in the Republic of Korea.

For more information, please visit www.shieldtherapeutics.com. Follow Shield on Twitter @ShieldTx

About KYE Pharmaceuticals Inc.

KYE Pharmaceuticals is a private company headquartered in Canada focused on bringing medications to the Canadian market which fulfill clinically significant and unmet needs. KYE has licensed many innovative products and was founded on an entrepreneurial spirit that optimizes our team's strengths and brings unique value to our partners, Canadian healthcare professionals, and most importantly, its patients.

For more information, please visit www.kyepharma.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 commercial strategy for Accrufer®/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 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.