Business Update

Progress towards the provision of $10 million of new equity by AOP Health by the end of 2024

Strong sales of ACCRUFeR® in the month of October 2024,

guidance reiterated to meet the Group revenue covenant target of $31.5 million for the full year 2024

London, UK, 21 November 2024: Shield Therapeutics plc (LSE: STX), the commercial stage pharmaceutical company specialising in iron deficiency, provides an update covering recent activities.

Clinical Program in China

The Phase 3 confirmatory study in China is jointly sponsored by Shield and its partner Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK), the exclusive license holder for the development and commercialisation of ACCRUFeR®/ FeRACCRU® in China, Hong Kong, Macau and Taiwan. This trial is the final study required to support the filing of an NDA in China for the commercialisation of Feraccru®/Accrufer and recruitment has recently been completed of adult patients with IBD and IDA. The Company expects the NDA to be filed with the Chinese National Medical Products Administration (NMPA) in 2025. Further details will be announced in due course.

AOP Health subscription

On 29 October 2024 the Company announced that it had entered into a non-binding term sheet with AOP Health International Management AG ("AOP Health") for the potential provision of $10 million of new equity. The Company is engaged with The Panel on Takeovers and Mergers (the "Takeover Panel") to seek a waiver from the obligation of AOP Health to make an offer under Rule 9 of the Takeover Code and expects to convene a meeting of Shield's shareholders (the "General Meeting") before the end of 2024.

ACCRUFeR® sales performance

Based on strong sales of ACCRUFeR® in October 2024, driven primarily by an increase in Net Selling Price to more than $225 per prescription compared to $167 per prescription in Q3 2024, the Company remains on track to meet the total Group revenue covenant target of $31.5 million for full year 2024 under the debt facility agreement with SWK Funding LLC.

Anders Lundstrom, interim CEO commented: "We are delighted that our partner, ASK, has completed recruitment into the confirmatory Phase 3 study that will support the filing in China to commericalise ACCRUFeR®/FeRACRRU®, significantly increasing the global availability of a welcome additional well-tolerated and effective therapeutic option for the treatment of IDA. In addition, solid growth of ACCRUFeR® revenues in October give us a promising outlook for the rest of the fourth quarter, leaving us on track to meet our 2024 Group revenue covenant target and market expectations for the year."

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.

Details of the ASKC109-LC-1 Phase 3 study

This study was based on the design of the Phase 3 study that supported the approval of ACCRUFeR®/FeRACCRU® in the EU, USA, and other countries. It is a multicenter, randomized, double-blind and placebo controlled 12 week study confirming the safety and efficacy of ferric maltol capsules (30mg elemental iron) as a twice-daily treatment of IDA in subjects with IBD (Ulcerative Colitis (UC) or Crohn's disease (CD)) where oral ferrous preparations have failed or cannot be used.