ACCRUFeR® Approved by Health Canada

London, UK, 27 August 2024: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company that delivers ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated specialty pharmaceutical product, to address a significant unmet need for patients suffering from iron deficiency (with or without anaemia), today announces that Health Canada has approved ACCRUFeR® (ferric maltol) as a prescription drug for the treatment of adults with iron deficiency anemia (IDA). This development allows Shield's partner, Kye Pharmaceuticals Inc. (Kye), to launch ACCRUFeR® in Canada. Shield will be responsible for all manufacturing and supply to the Canadian market.

In accordance with the collaborative agreement, Shield is now due to receive a £250,000 milestone payment. For the remaining term of the agreement, Shield will receive additional revenue-based milestone payments along with double-digit royalties on net sales of ACCRUFeR®.

Anders Lundstrom, Interim CEO of Shield, commented: "We are delighted with the progress made in partnership with Kye since the signing of the license agreement in January 2022. Both organisations have demonstrated excellent collaboration and are driven to make ACCRUFeR® available to patients in Canada with iron deficiency as quickly as possible. Shield Therapeutics is committed to bringing ACCRUFeR®/FeRACCRU® to patients with iron deficiency around the world, and Canada is an important component of that mission."

John McKendry, President and CEO of Kye, commented: "ACCRUFeR® will be the only prescription oral therapy available in Canada to treat patients who continue to suffer from low iron despite attempts at treatment with other currently available options. Our partnership with Shield and the granting of marketing authorization for ACCRUFeR® in Canada grant us the opportunity to bring a novel, high-quality therapeutic option to patients in Canada who are struggling to address mild to moderate iron deficiency or iron deficiency anemia."

Clinically low iron levels (aka iron deficiency, ID) can cause serious health problems for adults of all ages, across multiple therapeutic areas. Together, ID and ID with anaemia (IDA) affect about 20 million people in the U.S. and represent a $2.3B market opportunity. As the first and only FDA approved oral iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet medical need for both physicians and patients.

In Canada, the Canadian Health Measures Survey (CHMS) estimates that 6.1% of the total Canadian population have ID, with females being more disproportionately affected (8.3%) versus males (4%). As the only Health Canada approved prescription oral iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet medical need for both physicians and patients.