Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical corporation studying in unindustrialized novel antibiotics, recently acknowledged economic consequences for the year ended December 31, 2k18.
Dr. Graham Lumsden, Chief Policymaking Officer, said: “Motif Bio had an extremely creative year in 2k18, including succumbing a New Drug Submission to the U.S. FDA for iclaprim for the conduct of patients with serious bacterial skin and skin construction contagions.
Inappropriately, in February 2k19 we unpredictably conventional a Comprehensive Rejoinder Letter from FDA informing Motif that the NDA for iclaprim could not be permitted as obtainable.
The Activity has asked for supplementary data to measure the probable for liver venomousness and we have a long-established FDA meeting date of May 3, 2k19 to debate the apprehensions noted in the Comprehensive Response Letter.
We imagine to be joined at the consultation by two exterior experts and antedate cooperative cooperation and hopefully a satisfactory path forward.
We believe that iclaprim can be an appreciated option for patients and their breadwinners who are in need of new antibiotic conduct options.”
Commercial and Development Highlights
- New Drug Application (NDA) accessible to and acknowledged for importance review by U.S. Food & Drug Administration (FDA) for iclaprim for the action of patients with acute bacterial skin and skin structure infections (ABSSSI).
- Announcement of Payment from the United States Patent and Characteristic Office for two patent submissions.
- The prerogatives narrate to the use of iclaprim to treat patients with microbial infections, counting but not incomplete to ABSSSI, hospital-attained bacterial pneumonia and Staphylococcus aureus lung infections in patients with cystic fibrosis. The two methods of use patents, which have now distributed, will decline in November 2k37.
- Results from the Phase III REVIVE-2 trial and pooled effectiveness and security consequences from the REVIVE-1 and -2 Phase III trials in ABSSSI published in peer-reviewed medical periodicals.
- Data on iclaprim security and efficacy and probable cost avoidance data obtainable at major medical discussions.
- Jonathan Gold elected interim Chief Financial Officer in February 2k18; Stephanie Noviello, MD, MPH joins as Vice President, Clinical Development in May 2k18.
Full Year 2k18 Financial Results Highlights
- Motif Bio specified a net loss of $14.0M or $(.05) per share, basic and $(.07) per share, diluted for 2k18, difference to $44.8M, or $(0.19) per share, basic and diluted for 2k17.
- Research and expansion expenditures reduced to $11.0M for 2k18, difference to $29.5M for 2k17.
- This diminution was mainly attributable to a $22.1Mlessening in disbursement for the iclaprim Phase III clinical trial program, which was talented in 2k17.
- This diminution was partially offset by a $3.6M raise in costs regarding supervisory and clinical operating happenings, chemistry engineering and control necessities and other non-clinical expansion activities.
- General and directorial costs were $7.6M for 2k18, difference to $8.5M in 2k17. This reduction was mainly attributable to a $0.4M reduction in stock-based recompense, which was higher in the 2k17 period incompletely because of a formerly exposed out-of-period correction and a $1.3Mlessening in legal, shareholder relations and other specialized fees. This diminution was partially offset by a $0.7M raise in employee cash reimbursement.
- Raised $12.7M of net incomes through the issuance of ordinary shares London’s AIM market.
- Cash and cash counterparts of about $12.3M as of December 31, 2k18.
- 296.7M ordinary shares unresolved as of December 31, 2k18.
Post Period End Highlights
- Received Comprehensive Response Letter (CRL) from FDA regarding NDA for iclaprim; Motif’s request to meet with the FDA to discuss the points elevated in the CRL was arranged and a meeting is planned for May 3, 2k19.
- Bruce Williams nominated interim Chairman following notification of Richard Morgan from Board of Directors.
- Raised $3.3M of net incomes through the issuance of commonplace dividends London’s AIM market.
- 342.5M ordinary shares unresolved as of April 11, 2k19.