Motif Bio PLC Filing of SEC Form F-3

TIDMMTFB

Motif Bio PLC

14 December 2017

This announcement shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws or any such state or jurisdiction.

Motif Bio plc

("Motif Bio" or the "Company")

Filing of SEC Form F-3

Motif Bio plc (AIM/NASDAQ: MTFB), a clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces that it has filed a Form F-3 registration statement with the United States Securities and Exchange Commission ("SEC"). This filing constitutes post-effective amendment No. 1 on Form F-3 to the Company's registration statement on Form F-1, SEC File No. 333-212491, which was the Company's registration statement filed in conjunction with the NASDAQ IPO and originally declared effective by the SEC on November 17, 2016 (the "Registration Statement"). The post-effective amendment has been filed pursuant to an undertaking in the Warrant Agent Agreement, dated November 23, 2016, between Motif Bio plc and The Bank of New York Mellon, as warrant agent, to keep current the information contained in the Registration Statement. The post-effective amendment specifically concerns the exercise of the warrants issued in connection with the Company's U.S. offering and European placement at the time of the Company's NASDAQ IPO. The information included in this filing updates and supplements the Registration Statement and the prospectus contained therein. No additional securities are being registered with respect to the post-effective amendment component of this filing.

Additionally, the Form F-3 registration statement registers the resale, from time to time, of up to 11,099,220 of the Company's ordinary shares (including some represented by American depositary shares) by certain selling shareholders named in the registration statement, which ordinary shares are issuable to the selling shareholders upon exercise of certain warrants that were previously issued by the Company in connection with the Loan and Security Agreement between Motif BioSciences Inc. and Hercules Capital, Inc. and warrants issued in private placement transactions in 2015 and 2010. No additional securities are being issued by the Company pursuant to this component of the filing.

Although the Form F-3 registration statement has been filed with the SEC, it has not yet become effective.

For further information, please contact:

 
 Motif Bio plc                                                               info@motifbio.com 
 Graham Lumsden (Chief Executive Officer) 
 Robert Dickey IV (Chief Financial Officer) 
 
 Walbrook PR Ltd. (UK FINANCIAL                 +44 (0) 20 7933 8780 / motifbio@walbrookpr.com 
  PR & IR) 
 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 )378-2963 
 Meggie Purcell                                                        mpurcell@troutgroup.com 
 
 Lazar Partners (US PR)                                              motiflp@lazarpartners.com 
 Chantal Beaudry                                                             +1 (646) 871-8480 
 Amy Wheeler                                                                 +1 (646) 871-8486

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(TM) 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.

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 plc's Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC's web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.

This information is provided by RNS

The company news service from the London Stock Exchange

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December 14, 2017 02:01 ET (07:01 GMT)

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