Publication of Report, Reinforcing FDA Approval

London, UK, 01 April 2026: Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that an independent peer-reviewed AdisInsight Report on ACCRUFeR®/FeRACCRU® (ferric maltol) has been published online in Pediatric Drugs, a leading international journal for healthcare professionals.

This report, titled Ferric Maltol: Pediatric First Approval, is available via the following link: https://link.springer.com/article/10.1007/s40272-026-00748-3

The publication reports on the recent US Food and Drug Administration (FDA) approval of the extension of the ferric maltol indication to include pediatric patients aged 10 years and over for the treatment of iron deficiency, which was supported by positive results from the Phase 3 pediatric clinical trial (FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of a new oral liquid pediatric formulation in children aged 1 month and above with iron deficiency, presenting as iron deficiency anemia (IDA).

Anders Lundstrom, CEO of Shield, commented: "Iron deficiency in children is a serious and often underdiagnosed condition, and today's publication in Pediatric Drugs underscores the clinical importance of having an approved, well-characterised treatment option for pediatric patients. The FDA's decision to extend the ferric maltol indication to patients aged 10 and over is a significant step forward, and we are committed to ensuring that both clinicians and patients can benefit from this approval as quickly as possible."

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 anemia (IDA) affect about 20 million people in the US 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 and is now the #1 branded prescription oral iron the market today (*data source - IQVIA Xponent PlanTrak).

Details of the FORTIS/ST10-01-305 Phase 3 study

(N = 30). Children 1 months to under 2 years (N=4) were all assigned to receive ferric maltol treatment. The full data sets have been submitted for peer-review and subsequent presentation/publication. The trial is the final study in the comprehensive pediatric development program that Shield committed to implement with both the European EMA and the US FDA.