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Shield Therapeutics - AEGIS-H2H update – non-inferiority at 24 weeks

Shield Therapeutics (STX) has announced a technical update to findings from the AEGIS-H2H post-marketing study. The re-analysis demonstrates that Feraccru/Accrufer is a credible alternative to IV iron therapy for iron deficiency anaemia (IDA) in the long term. We note the product did not meet the primary endpoint of non-inferiority at 12 weeks vs IV iron, but did correct anaemia and maintain Hb levels over the long term phase (as defined by the 40-week extension phase of the trial). While we note AEGIS H2H was not required as a registration study (thus the regulatory status of the product is unaffected by the study), the headline results of long-term Hb correction is comparable to IV iron for chronic conditions of anaemia. We believe this will have positive implications for health economic outcomes, pricing strategies and partnering opportunities. The next key inflection point is a US partnering deal; we expect Accrufer launch later this year once a partner has been found. Our valuation of STX is unchanged at £381.7m or 326p/share.