Motif Bio PLC Motif Bio Notes Statement from Amphion Innovations (2555C)

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RNS Number : 2555C

Motif Bio PLC

28 September 2018

Motif Bio plc

("Motif Bio" or the "Company")

Motif Bio Notes Statement from Amphion Innovations

Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, notes the announcement made today via RNS by Amphion Innovations plc ("Amphion"), a substantial shareholder in the Company, that Amphion had reached an agreement in principle, subject to entering into a binding agreement, to extend the repayment of the loan facility by one year until 30 September 2019. Amphion's loan facility is secured by 24,475,591 ordinary shares of Motif Bio beneficially held by Amphion. Amphion currently owns a total of 25,254,611 ordinary shares of Motif Bio.

For further information please contact:

 
 Motif Bio plc                                                     [e-mail] 
 Graham Lumsden (Chief Executive 
  Officer) 
 
 
 Peel Hunt LLP (NOMAD & BROKER)                                 + 44 (0)20 7418 8900 
 Dr. Christopher Golden 
 Oliver Jackson 
 
 
 Northland Capital Partners Limited 
  (BROKER)                                                       [phone] 
 David Hignell/Vadim Alexandre/Rob 
  Rees 
 
 
 Walbrook PR Ltd. (UK FINANCIAL 
  PR & IR)                                                      [phone] 
 Paul McManus/Helen Cresswell/Lianne 
  Cawthorne 
 
 
 MC Services AG (EUROPEAN IR)                                     [phone] 
 Raimund Gabriel                                      [e-mail] 
 
 
 Solebury Trout (U.S. IR)                                         + 1 [phone] 
 Meggie Purcell                                              [e-mail] 
 
 Russo Partners (U.S. PR)                              [phone] or +1 (212) 
                                                                            845 4272 
 David Schull                                      [e-mail] 
 Travis Kruse, Ph.D.                               [e-mail] 
 
 
 

Note to Editors:

About Motif Bio

Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage biopharmaceutical company focused on developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant Gram-positive bacteria, including MRSA. The Company's lead product candidate is iclaprim. Following positive results from two Phase 3 trials (REVIVE-1 and REVIVE-2), a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is now under review, with a PDUFA date of February 13, 2019. More than 3.6 million patients with ABSSSI are hospitalised annually in the U.S. It is estimated that up to 26% of hospitalized ABSSSI patients have renal impairment.

The Company also plans to develop iclaprim for hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), as there is a high unmet need for new therapies in this indication. A Phase 2 trial in patients with HABP has been successfully completed and a Phase 3 trial is being planned. Additionally, iclaprim has been granted orphan drug designation by the FDA for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis and is in preclinical development for this indication.

Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track status for the ABSSSI indication. If approved for the ABSSSI indication as a New Chemical Entity, iclaprim will be eligible for 10 years of market exclusivity in the U.S. from the date of first approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act). In Europe, 10 years of market exclusivity is anticipated. Motif is also building a patent estate to provide additional protection for iclaprim and has recently received . Notices of Allowance from the United States Patent and Trademark Office for two method of use patents that will expire in 2037.

Forward-Looking Statements

This press release contains forward-looking statements. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio's product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio's product candidates, (iii) Motif Bio's ability to successfully commercialise its product candidates, (iv) Motif Bio's ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio's commercialisation, marketing and manufacturing capabilities and strategy, (vi) Motif Bio's expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio's product candidates, (viii) Motif Bio's ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio's estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled "Risk Factors" in Motif Bio's Annual Report on Form 20-F filed with the SEC on April 10, 2018, which is available on the SEC's web site, www.sec.gov. Motif Bio undertakes no obligation to update or revise any forward-looking statements.

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 [e-mail] or visit www.rns.com.

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September 28, 2018 02:03 ET (06:03 GMT)