Presentation

Company Profile
Moberg Pharma focuses on developing MOB-015, a topical treatment for nail fungus, based on the known substance terbinafine, delivered in a novel formulation. Moberg has signed licensing agreements for MOB-015 for Europe, Japan, South Korea and Canada. MOB-015 has recently been evaluated over 52 weeks in two randomized, multicenter, controlled phase 3 studies including more than 800 patients in North America and Europe. Both studies showed a high level of mycological cure vs the control arm with low complete cure, although higher than the control arm, but lower vs oral terbinafine. While the formulation delivers high levels of terbinafine, it also confounds the assessment of clinical cure and complete cure. A likely solution to this problem would be a shorter dosing regimen. The company will go ahead and submit application for approval in the EU.

Recent highlights
Cash flow in Q2 was SEK 1.5m. Moberg ended Q2 with SEK 124m in cash and cash equivalents.

Outlook
In the near term, the focus is on registration preparations for MOB-015 with the goal of submitting a registration application in the second half of 2021 in Europe. With an expected processing time of about 1.5 years, this means possible approval in H1 2023 and launch in Europe by the end of 2023.