Motif Bio to Present at the 7th Annual Trout Group Hamptons CEO Roundtable Conference on August 17th

NEW YORK, Aug. 14, 2017 -- Motif Bio plc (AIM:MTFB) (NASDAQ:MTFB) ("Motif" or the "Company"), the clinical stage biopharmaceutical company specializing in developing novel antibiotics, announced today that CEO Graham Lumsden will present an overview of the company and near-term value drivers for its flagship product, Iclaprim, which is in late Phase 3 clinical trials as part of The Catalyst Hour at the 7th Annual Trout Group Hamptons CEO Roundtable Conference. The conference will take place on August 17th, 2017 in Bridgehampton, New York.

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Notes to Editors

About Iclaprim 

Iclaprim is a novel antibiotic that has a different and underutilised mechanism of action compared to other antibiotics. Iclaprim exhibits potent activity against Gram-positive clinical isolates of many genera of staphylococci, including methicillin resistant Staphylococcus aureus (MRSA). Iclaprim is rapidly bactericidal, achieving 99.9% in-vitro kill against MRSA within 4 to 6 hours of drug exposure versus 8 to 10 hours for vancomycin. To date, iclaprim has been studied in over 1,300 patients and healthy volunteers. Iclaprim is administered intravenously at a fixed dose with no dosage adjustment required in patients with renal impairment, or in obese patients. The iclaprim fixed dose may help reduce the resources required in hospitals since dosage adjustment by health care professionals is avoided and overall hospital treatment costs may be lower, especially in renally impaired patients.

About Motif Bio

Motif Bio plc (AIM: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 (methicillin-resistant Staphylococcus aureus). 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 U. S. The Company believes that iclaprim is suitable for first-line empiric therapy in ABSSSI patients, especially those with renal impairment, with or without diabetes, due to its underutilised mechanism of action, targeted spectrum of activity, low propensity for resistance development, fixed dose administration, clearance of inactive metabolites through the kidneys and favourable tolerability profile. 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 and iclaprim has demonstrated initial evidence of efficacy in a Phase 2 trial in patients with HABP. Additionally, in a clinical study evaluating the tissue distribution of an IV dose of Iclaprim in relevant lung compartments, high concentrations were found in epithelial lining fluid and alveolar macrophages, achieving levels up to 20- and 40-fold higher, respectively, than in plasma. Iclaprim has been studied in an animal model of chronic pulmonary MRSA infection which mimics the pathophysiology observed in patients with cystic fibrosis. Data will be presented at ID Week in October 2017. Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track status. Upon acceptance of the 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.