Shield Therapeutics (LON:STX) New Drug Submission accepted by Health Canada

Accrufer® New Drug Submission accepted by Health Canada

NDS filed by Partner, KYE Pharmaceuticals Inc., for Regulatory Review has been accepted

Marketing approval expected mid-2023

London, UK – 14 July 2022: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company with a focus on treating iron deficiency with its lead product Accrufer®/Feraccru®, announces that Health Canada have screened and accepted the Accrufer® New Drug Submission (“NDS”), filed by Shield’s Licensing Partner, KYE Pharmaceuticals Inc. (“KYE”) earlier this year.

Health Canada are expected to complete their regulatory review in mid-2023 and a successful outcome will allow KYE to market Accrufer® in Canada. Shield will be responsible for all manufacturing and supply to the Canadian market.

Upon regulatory approval of Accrufer® by Health Canada, Shield is due to receive a £250,000 milestone payment. In addition, Shield would be eligible for an additional £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®.

For further information please contact:

Shield Therapeutics plc

Greg Madison, CEO

+44 (0) 191 511 8500

Hans-Peter Rudolf, CFO

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