STOCKHOLM: The Board of Directors of Moberg Pharma AB has resolved to carry out a fully guaranteed issue of new ordinary shares with preferential rights for existing shareholders of approximately SEK 121 million before transaction costs.
The Rights Issue is conditional upon approval at an extraordinary general meeting. The net proceeds will be used for registration activities and clinical work for MOB-015.
“The financing we have secured gives us the opportunity to fully exploit MOB-015’s potential, both through the registration activities and launch preparations in Europe and an additional clinical study for the US market. The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect,” says Anna Ljung, CEO of Moberg Pharma.
Background and reason
Moberg Pharma is a Specialty Pharma company that focuses on the commercialisation of proprietary drugs based on proven substances. The goal is to take the Company’s product MOB-015, which is in the registration phase in Europe and phase-3 in North America, to a world-leading position in the treatment of nail fungus.
The Company intends to repeat the journey made with Kerasal Nail®, the Company’s first-generation nail fungus product, where direct sales in the US were combined with strategic collaborations in multiple major regions. MOB-015 is the next generation of nail fungus treatment that targets both over-the-counter and prescription markets worldwide.
The Company’s patented formulation technology facilitates the delivery of high concentrations of a proven antifungal substance (terbinafine) into and through the nail, enabling rapid elimination of the fungal infection.
The Company has secured contracts for commercialisation of MOB-015 with aggregate milestone payments of USD 120 million, in addition to compensation for delivered products, with strong partners in the EU, Japan, Canada and South Korea. MOB-015 has the potential to be the market-leading medication globally as the product has a world-leading ability to kill nail fungus (> 70 percent, compared to 30-55 percent for today’s topical treatments).
The Company believes there is strong demand and an opportunity for rapid acceptance of a new, effective topical product as 100 million nail fungus patients in the EU and North America currently lack good treatment alternatives.
Since the primary endpoint was achieved in both the North American phase-3 study and the European phase-3 study, these two studies are expected to be used as a basis for product registration in Europe. The Company intends to obtain market approval and launch MOB-015 in Europe in 2023.
The Company is also preparing for a further phase-3 study in North America for which documentation has been submitted to the FDA and the Company expects to start enrolling patients in the second quarter of this year. The purpose of the new study is to facilitate market approval in the US as well as strengthen the product’s clinical evidence and marketing claims globally. The Company’s assessment is that the market potential for MOB 015 amounts to MUSD 250–500 annually.
Use of issue proceeds
Moberg Pharma intends to use the net proceeds to finance registration activities and clinical work for MOB-015 as well as preparations for launch in Europe in 2023.
Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. www.mobergpharma.se