UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934

 

For the Month of: December 2017

 

Commission File Number: 001-37847

 

MOTIF BIO PLC

(Exact name of registrant as specified in its charter)

 

125 Park Avenue

25th Floor

New York, New York 10011

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F x Form 40-F o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o

 

 

 



 

MOTIF BIO PLC

FORM 6-K

 

MOTIF BIO NOTES STATEMENT FROM AMPHION INNOVATIONS

 

On December 22, 2017, Motif Bio plc (the “Company”) issued a regulatory news service (“RNS”) announcement, a copy of which is attached as Exhibit 99.1 to this report on Form 6-K, noting that Amphion Innovations plc (“Amphion”), a substantial shareholder in the Company, issued an RNS announcement relating to the successful restructuring of its loan facility and the extension of the timetable for repayment.  Amphion’s loan facility is secured by 36,371,625 ordinary shares of the Company beneficially held by Amphion.

 

This report on Form 6-K (including the exhibits hereto) shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

Exhibits

 

Exhibit 99.1

 

Regulatory news service announcement issued by Motif Bio plc, dated December 22, 2017, entitled “Motif Bio notes statement from Amphion Innovations.”

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

MOTIF BIO PLC

 

 

 

 

By:

/s/ Graham Lumsden

 

Name: Graham Lumsden

 

Title: Chief Executive Officer

 

Date: December 22, 2017

 

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Exhibit 99.1

 

 

22 December 2017

 

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, relating to the successful restructuring of its loan facility and the extension of the timetable for repayment.  Amphion’s loan facility is secured by 36,371,625 ordinary shares of Motif Bio beneficially held by Amphion.

 

For further information, please contact:

 

Motif Bio plc

info@motifbio.com

Graham Lumsden (Chief Executive Officer)

 

Robert Dickey IV (Chief Financial Officer)

 

 

 

Peel Hunt LLP (NOMAD & BROKER)

+ 44 (0)20 7418 8900

Dr Christopher Golden

 

Oliver Jackson

 

 

 

Northland Capital Partners Limited (BROKER)

+44 (0)203 861 6625

Patrick Claridge/ David Hignell

 

John Howes/ Rob Rees (Broking)

 

 

 

Walbrook PR Ltd. (UK FINANCIAL PR & IR)

+44 (0) 20 7933 8780 / motifbio@walbrookpr.com

Paul McManus

Mob: +44 (0)7980 541 893

Mike Wort

Mob: +44 (0)7900 608 002

 

 

MC Services AG (EUROPEAN IR)

+49 (0)89 210 2280

Raimund Gabriel

raimund.gabriel@mc-services.eu

 

 

The Trout Group (US IR)

+1 (646 )378-29363

Meggie Purcell

mpurcell@troutgroup.com

 

About Motif Bio

 

Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage biopharmaceutical company engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalised patients caused by multi-drug resistant bacteria, including MRSA. The Company’s lead product candidate, iclaprim, is being developed for high-risk MRSA patient populations. The first proposed indication, and near-term commercial opportunity, is for the treatment of acute bacterial skin and skin structure infections (ABSSSI), one of the most common bacterial infections, with 3.6 million patients hospitalised annually in the US. The Company believes that iclaprim may be suitable for first-line empiric therapy in ABSSSI patients, especially those with renal impairment, with or without diabetes. Unlike current standard of care antibiotics, in clinical

 



 

trials to date, nephrotoxicity has not been observed with iclaprim and dosage adjustment has not been required in patients with renal impairment.

 

Iclaprim has an underutilised mechanism of action compared to other antibiotics. Clinical and microbiology data indicate iclaprim has a targeted gram-positive spectrum of activity, low propensity for resistance development, fixed dose administration and favourable tolerability profile. Additionally, data support that the inactive metabolites of iclaprim clear through the kidneys. 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 was conducted to study iclaprim in patients with HABP. Iclaprim has been studied in an animal model of chronic pulmonary MRSA infection which mimics the pathophysiology observed in patients with cystic fibrosis. Results from this study were presented at IDWeek 2017™ on 6 October 2017 in San Diego, CA. Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track status. Upon acceptance by the FDA of a New Drug Application (NDA), iclaprim will receive Priority Review status and, if approved as a New Chemical Entity, 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 data exclusivity is anticipated.