Motif Bio PLC (LON:MTFB), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced financial results for the year ended December 31, 2016.
Motif Bio made significant progress in 2016 towards our goal of bringing our novel antibiotic candidate, iclaprim, to patients with serious and life-threatening infections. The announcement of positive Phase 3 topline results for iclaprim in REVIVE-1 was a major achievement for Motif Bio and we expect to announce the top line data from REVIVE-2, the second Phase 3 trial, in the second half of 2017, commented Graham Lumsden, CEO of Motif Bio plc.
Recent Corporate Developments
· Announced positive topline results for iclaprim in the REVIVE-1 Phase 3 study of ABSSSI
· Data from REVIVE-2, which uses an identical protocol to REVIVE-1 but has different trial centres, has more than 80% of the total patients enrolled, and data is expected in the second half of 2017
· Achieved a NASDAQ listing
· Closed a U.S. initial public offering and a concurrent European placement with aggregate net proceeds of $21.5 million, which brought the total raised by the Company to approximately $65 million
· Appointed Robert Dickey IV as Chief Financial Officer
· Presented two posters at ID Week 2016.The first showed new data demonstrating that iclaprim is highly potent in vitro against bacterial strains associated with clinical Hospital Associated Bacterial Pneumonia (“HABP”) and Skin and Skin Structure Infections (“SSSI”) clinical isolates. The second poster described the potential benefits of an optimized 80mg fixed dose of iclaprim administered intravenously over 120 minutes, that is being used in the REVIVE Phase 3 clinical trials. Improvement by approximately 30% in the PK/PD parameters associated with efficacy, AUC/MIC and t/MIC, was seen compared to the previously studied weight based dose of 0.8 mg/kg.
· Completed preparations for INSPIRE, a Phase 3 trial designed to study the safety and efficacy of iclaprim in patients with HABP, including VABP
· Completed additional research with clinicians and payers to understand how iclaprim may be able to address the unmet need in hospitalized ABSSSI patients with renal impairment with/without diabetes
Full Year 2016 Financial Results
· For the full year, Motif Bio reported a net loss of $40.3 million, or $(0.35) per share (basic and diluted) compared to a net loss of $8.5 million, or $(0.14) per share (basic and diluted) during the same period in 2015.
· Research and development (R&D) costs for 2016 were $34.8 million compared to $4.7 million during 2015. Higher R&D costs in 2016 were primarily attributable to the commencement of iclaprim clinical development. Clinical development expenses are a significant component of our research and development expenses and product candidates in later stage development generally have higher costs.
· General and administrative expenses for 2016 were $4.9 million compared to $3.6 million during 2015. The increase is primarily due to the costs associated with the filing of a registration statement relating to the initial public offering in the U.S.; costs associated with being a public company in both the United Kingdom and the U.S.; and increases in the costs of outside professional services.
· Cash and cash equivalents were $21.8 million as of December 31, 2016.
· As of December 31, 2016, the Company had 195.7 million ordinary shares outstanding.
Motif Bio has filed its U.S. Annual Report on Form 20-F for the year ended December 31, 2016 with the US Securities and Exchange Commission (“SEC”). The Form 20-F is available to download, either from the Investors section of the Company website at www.motifbio.com or from the SEC website at www.sec.gov.
About iclaprim
Iclaprim is a potential novel antibiotic, designed to be effective against bacteria that have developed resistance to other antibiotics, including trimethoprim. Iclaprim exhibits potent in vitro activity against Gram-positive clinical isolates of many genera of staphylococci, including methicillin sensitive Staphylococcus aureus (MSSA) and methicillin resistant Staphylococcus aureus (MRSA). The MIC90 of iclaprim was lower than most comparators including vancomycin and linezolid, standard of care therapies used in serious and life-threatening Gram-positive hospital infections. To date, iclaprim has been studied in over 1,000 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. This may help reduce overall hospital treatment costs, especially in renally impaired patients.
About Motif Bio plc www.motifbio.com
Motif Bio 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. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having completed the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017.
