London - Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru /Accrufer (ferric maltol), announces its preliminary Group results for the year ended 31 December 2019.

Operational highlights

FDA approved Accrufer with a broad label for treating iron deficiency in adults

Positive long term data from AEGIS-H2H (head-to-head) clinical study comparing Feraccru/Accrufer to IV iron although the study did not meet its primary end point at 12 weeks

The H2H study demonstrated that Feraccru/Accrufer offers a simple, well tolerated and efficacious oral treatment alternative to IV iron therapy, without the need for hospital-based administration

Long term phase of AEGIS-CKD study shows haemoglobin levels increased and maintained across 52 weeks of Feraccru therapy in patients with chronic iron deficiency anaemia (IDA)

Swissmedic approved Feraccru to treat iron deficiency with or without anaemia in adults

Financial highlights

Revenues of GBP0.7 million (2018: GBP11.9 million)

Loss for the year of GBP8.8 million (2018: GBP1.8 million)

Net cash of GBP4.1 million (2018: GBP9.8 million)

Post-period highlights

Exclusive licence agreement with Beijing Aosaikang Pharmaceutical Co. Ltd ('ASK Pharm') for the development and commercialisation of Feraccru/Accrufer in China

Deal highlights

US$11.4 million upfront licence payment to Shield

Up to US$51.4 million in development and sales milestones

Ongoing tiered double-digit royalties on net sales payable to Shield

ASK Pharm to be responsible for, and cover costs of, all development and regulatory activity

Agreed to repay EUR2.5 million milestone to Norgine, originally received in respect of AEGIS-H2H clinical study in the first half of 2019

Commenting on the preliminary results, Tim Watts, CEO of Shield Therapeutics plc, said: 'I am honoured to have been appointed as CEO at this important time for Shield. 2019 was a very successful year for Shield with the approval of Accrufer by the FDA for marketing in the USA and the positive long-term results from the AEGIS-H2H clinical study, and the conclusion in January 2020 of the licence agreement with ASK Pharm in China. Our top priority is now to conclude a partnering agreement in the USA during 2020.'

Contact:

Tim Watts

Tel: +44 (0)20 7186 8500

Web: www.shieldtherapeutics.com

About Shield Therapeutics plc

Shield is a de-risked, commercial stage, specialty pharmaceutical company delivering innovative pharmaceuticals to address patients' unmet medical needs. The Company's clear purpose is to develop products that help patients become people again, enabling them to enjoy the things that make a difference in their everyday lives. The Group's lead product, Feraccru/ Accrufer has exclusive IP rights until the mid-2030s and is approved for the treatment of iron deficiency with or without anaemia in adults in the European Union, the United States and Switzerland. In Europe it is marketed as Feraccru with commercialisation led by Norgine BV and in the USA the product will be marketed as Accrufer with Shield currently in the process of selecting a commercialisation partner. Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical Co. Ltd for the development and commercialisation of Feraccru/Accrufer in China, Hong Kong, Macau and Taiwan.

About Feraccru /Accrufer

Feraccru /Accrufer is a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia that has been shown to be an efficacious and well-tolerated therapy in a range of controlled phase 3 trials, including positive results from the Phase IIIb AEGIS-H2H study in which Feraccru/Accrufer demonstrated it was non-inferior in delivering improvements in haemoglobin levels compared to intravenously-administered (IV) Ferinject/Injectafer (ferric carboxymaltose). Feraccru/Accrufer therefore offers a compelling alternative to IV iron for those patients unable to tolerate salt-based oral iron therapies and wish to avoid the complexities of infusion-based iron therapies.

When salt-based oral iron therapies are ingested they can cause a range of mild-to-severe gastrointestinal tract (GI) adverse events, including nausea, bloating and constipation through the release and subsequent reactivity of free iron in the GI tract, leading to poor tolerability, reduced patient compliance and ultimately treatment failure. Feraccru/Accrufer is not an iron saltand, as a result, it does not routinely cause the same treatment-limiting intolerance issues of salt-based iron therapies, whilst the iron from the ferric maltol molecule can be readily absorbed.

Prior to Feraccru /Accrufer, IV iron therapies were the only realistic alternative treatment option for iron deficient patients with or without anaemia intolerant of or unwilling to be treated salt-based oral iron therapies. However, use of such an invasive, costly, inconvenient and complex to administer treatment option, which is associated with potentially life-threatening and spontaneous hypersensitivity reactions, means there remains a clear unmet medical need for these patients to have access to an effective therapy that is well tolerated, convenient and does not require hospital-based administration. Feraccru/Accrufer meets those requirements.

About Iron Deficiency

The WHO states that iron deficiency is the most common and widespread nutritional disorder in the world. As well as affecting a large number of women and children in non-industrialized countries, it is the only nutrient deficiency which is also significantly prevalent in virtually all industrialised nations. There are no current global figures for iron deficiency but, using anaemia as an indirect indicator, it can be estimated that most preschool children and pregnant women in non-industrialised countries, together with at least 30-40% in industrialized countries, are iron deficient.

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. 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.

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