Motif Bio hit by regulatory setback but losses narrow

Motif Bio on Monday reported a narrowed annual loss on the back of a reduction in research and development expenses as it seeks regulatory approval for its iclaprim skin infection treatment despite an early setback.

The clinical-stage biopharmaceutical company, which has yet to reach the commercial stage, recorded a loss before tax of $14.0m for 2018, down from a loss of $44.8m in the year before, as research and development costs dipped from $29.5m to $11.0m.

The AIM traded company said this was primarily attributable to a $22.1m reduction in expense for the iclaprim Phase III clinical trial program, which was completed in 2017.

Graham Lumsden, chief executive of Motif Bio, said: "Motif Bio had an incredibly productive year in 2018, including submitting a new drug application to the US FDA for iclaprim for the treatment of patients with acute bacterial skin and skin structure infections. Unfortunately, in February 2019 we unexpectedly received a complete response letter from FDA notifying Motif that the NDA for iclaprim could not be approved as submitted."

Chairman Bruce Williams added that the company is now focused on working with the FDA to address the concerns raised in its complete response letter to the group, which include a request for additional data to assess Iclaprim's potential for liver toxicity, with the goal of finding the best path to move the treatment towards approval.

The application for the drug's approval sought its use to treat patients with bacterial infections, including but not limited to ABSSSI, hospital-acquired bacterial pneumonia and Staphylococcus aureus lung infections in patients with cystic fibrosis, while there are also plans to develop iclaprim for hospital acquired bacterial pneumonia.

At the end of the year, Motif Bio remained well funded with cash and cash equivalents of $12.3m, down from $22.7m at the same point the year before.

"The group does not expect to generate significant revenue from product sales unless and until the group obtains regulatory approval for and successfully commercializes iclaprim or future product candidates. The group anticipates that it will continue to generate losses for the foreseeable future as the group continues the development of and/or seeks regulatory approvals for iclaprim and any future product candidates and begins to commercialize any approved products," said a statement from Motif Bio.

Motif Bio's shares were down 3.90% at 8.43p at 1137 BST.