Amphion Innovations plc

Statement re. Motif Bio plc

London and New York, 14 February 2019 - Amphion Innovations plc (AIM:AMP), the developer of medical, life science, and technology businesses, notes today’s announcement from Partner Company, Motif Bio plc (“Motif”) that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

The CRL states that the FDA cannot approve the NDA in its present form and indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved. Motif plans to request a meeting with the FDA as soon as possible to discuss potential options to address the deficiencies.

At 31 December 2018, Motif had cash of $12.3 million and $15 million of debt drawn from its Hercules loan facility. Motif is financed into the second quarter of 2019 but will need to raise capital in the near term. 

Richard Morgan, CEO of Amphion Innovations plc, commented: 
“This is disappointing news for Motif, but they will be requesting a meeting with the FDA to discuss the CRL and to discuss options to advance iclaprim towards approval. We look forward to further updates from Motif in the future.”

 

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For further information please contact

Amphion Innovations
Charlie Morgan
+1 212 210 6224

Panmure Gordon Limited (Nominated Adviser and Corporate Broker)
Freddy Crossley / Emma Earl (Corporate Finance)
Charlie Leigh-Pemberton (Corporate Broking)
+44 (0)20 7886 2500

SP Angel Corporate Finance LLP (Joint Corporate Broker)
David Hignell (Corporate Finance)
Rob Rees (Corporate Broking)
+44 (0)20 3470 0470

Walbrook PR
Anna Dunphy / Paul McManus
+44 (0)20 7933 8780

About Amphion Innovations plc
Amphion Innovations is a developer of medical, life science and technology businesses.

We use our extensive experience in company building to invest and build shareholder value in high growth companies in the US and UK. Amphion has significant shareholding in a small number of Partner Companies developing proven technologies targeting substantial commercial marketplaces. The Amphion model has been refined to optimise the commercialisation of patents and other intellectual property within the Partner Companies.