Shield Therapeutics announced its preliminary results for the year ended December 2018. Net cash stood at £9.8m (FY2017: £13.3m), while loss for the year was £1.8m (FY2017: £19.6m).
Positive results were witnessed for the pivotal Phase III AEGIS-CKD study of Feraccru vs. placebo. Approval for Feraccru was broadened to a market of 40m patients, all adults with iron deficiency in Europe with or without anaemia. The company also completed recruitment for its AEGIS-H2H Phase IIIb study of oral Feraccru vs. intravenous iron therapy.
So far, the company witnessed positive results for AEGIS-H2H non-inferiority study, prompting a €2.5m development milestone receivable from Norgine. Positive results were achieved in the long-term follow-up of patients enrolled in the AEGIS-CKD clinical study as well. Presently, Norgine has started the promotion of Feraccru® in the UK and Germany.
Carl Sterritt, Shield Therapeutics’ CEO, said: “2018 was a year of transition and Shield is now well positioned to deliver further positive news through 2019. In the US I look forward to the 27 July 2019 PDUFA date, which has the potential to unlock the world’s largest prescription pharmaceutical market to Feraccru®, which has continued to demonstrate its effectiveness over the last 12 months in two demanding clinical trials.”