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Share Name Share Symbol Market Type Share ISIN Share Description
Amphion Innovations LSE:AMP London Ordinary Share GB00B0DJNP99 ORD 1P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  +0.05p +13.33% 0.425p 0.40p 0.45p 0.425p 0.375p 0.375p 624,623 13:44:21
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
General Financial 0.1 -13.6 -7.3 - 0.89

Amphion Innovations PLC Statement re. Motif Bio plc

14/02/2019 8:00am

UK Regulatory (RNS & others)


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RNS Number : 9974P

Amphion Innovations PLC

14 February 2019

Amphion Innovations plc

("Amphion" or "the Company")

Statement re. Motif Bio plc

London and New York, 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."

For further information please contact:

 
 Amphion Innovations                                                                   Tel: +1 (212) 210 6224 
 Charlie Morgan 
 
 Panmure Gordon Limited (Nominated Adviser                                           Tel: +44 (0)20 7886 2500 
  and Corporate Broker) 
 Emma Earl/ Freddy Crossley (Corporate 
  Finance) 
 Charles Leigh-Pemberton (Corporate 
  Broking) 
 
 SP Angel Corporate Finance LLP (Joint Corporate                                        Tel: +44 20 3470 0470 
  Broker) 
 David Hignell (Corporate Finance) 
 Vadim Alexandre (Corporate Broking) 
 
 Walbrook PR                                               Tel: +44 (0)20 7933 8780 or amphion@walbrookpr.com 
 Anna Dunphy / Paul 
  McManus 
 
 
 

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 7 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. The Partner Companies collectively own or control over 200 separately identified pieces of intellectual property, a number which grows rapidly each year.

On the web: www.amphionplc.com

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

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February 14, 2019 03:00 ET (08:00 GMT)

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