Moberg Pharma (MOB) Study Update summary

Study update and preliminary findings

• Blinded interim data from a North American Phase III study for MOB-015 showed lower-than-expected clinical cure rates, increasing the risk of not meeting the primary endpoint and impacting U.S. commercialization prospects.

• Only clinical cure data from a blinded subset was available, and it was below expectations; complete cure requires clinical cure, negative fungal culture, and negative microscopy.

• The study involves 384 patients at 33 centers in the US and Canada, using a modified dosing regimen compared to previous EU studies.

• The company does not know which patients received the drug or the proportion in the subset, and the press release was legally required after receiving this unexpected data.

• The company is expediting topline data release before year-end and will not speculate on final outcomes until results are available.

Implications for regulatory and commercial strategy

• The EU product uses a different dosing regimen and is already approved in 13 countries, so no regulatory consequences are expected in Europe from this trial.

• Launch timing in Europe depends on approval of a new terbinafine supplier and pharmacy chain logistics, targeting peak season 2026.

• The Canadian filing will rely on the European dossier, and the U.S. study outcome is not expected to impact Canadian approval; other markets like Israel and Canada can use the European data, while China and Japan will require local studies.

• The main bottleneck for broader EU launch is terbinafine supply approval, not the U.S. study outcome.

• The company will analyze top-line data expected in December before making further strategic decisions.

Product and market context

• MOB-015 is a topical terbinafine formulation designed to deliver effective concentrations to the nail while avoiding systemic side effects.

• Onychomycosis affects 10% of the population, with a significant unmet need for safer, more effective treatments.

• MOB-015 is marketed as TerclaraⓇ in Sweden, available at all pharmacy chains, and has commercial partnerships in Europe and Canada.

• Over 800 patients have participated in Phase 3 trials for MOB-015, supporting its potential as a future market leader.

• No immediate sales impact is expected in Sweden, as the market is OTC and based on previous studies.