Moberg Pharma´s Interim report January - March 2023
REGISTRATION PROCESS ONGOING, 120-DAY REPORT AND 145-DAY QUESTIONS RECEIVED
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SIGNIFICANT EVENTS IN THE FIRST QUARTER
- The company regains full rights to MOB-015 in Japan
- The management team is strengthened with the addition of Jesper Lind, Head of Supply.
SIGNIFICANT EVENTS AFTER THE QUARTER
- The North American study is progressing as planned and all patients are expected to be enrolled by the end of the year
- Progress according to plan with regulatory interactions in the EU, 120-day report and subsequent 145-day questions received
- The Nomination Committee proposes Håkan Wallin as a new member of the Board of Directors
STATEMENT FROM THE CEO
We remain fully focused on our two most important activities: the registration process for the nail fungus treatment MOB‐015 in Europe and patient enrollment in the North American Phase 3 study. Both the registration process and the clinical study are progressing as planned with key value-creating milestones in 2023.
The registration process in Europe is now in an intensive phase. We have received the 120-day report and subsequent 145-day questions. Moberg Pharma has submitted a full registration application through the decentralized process, which offers the possibility of data exclusivity in Europe for up to 10 years following market approval. Our goal is to receive the first market approval in 2023.
Together with our partners, we are fully focused on the registration process and are working diligently to formulate the best possible responses to questions from the regulatory authorities. It is a strength for a small company like Moberg Pharma to collaborate with experienced distributors and partners who know their local markets. In total, we have five partnerships in place, including for the EU and Canada. During the quarter, Moberg Pharma regained full rights to MOB-015 in Japan, while the company retains paid milestone revenues of USD 5 million. This was after our partner conducted an extensive strategic review of its R&D pipeline and decided that the program no longer aligns with its business strategy. This enables potentially new partnerships in Japan going forward.
In March, the American Academy of Dermatology (AAD) held its annual meeting in New Orleans, where we took part and met a majority of the physicians involved in the ongoing North American Phase 3 study. We had many inspiring discussions that underscore the great medical need for a product with MOB-015’s profile as well as the enthusiasm of the physicians for the clinical study. In total, more than 30 clinics in the U.S. and Canada are admitting nail fungus patients. The study is progressing as planned and we expect to complete patient enrollment during the year. Since the patients are evaluated over 52 weeks and it takes time to culture fungal samples from the last patient’s last visit, we expect to be able to present topline data 15 months after the last patient is enrolled, in Q1 2025. The study will include a total of 350 patients with nail fungus. The study design builds on the experience gained from the previous Phase 3 studies and Moberg Pharma is cooperating with the same CRO, same lead investigator and high‐performance clinics from the previous North American study.
We continue to take important steps towards the commercial phase and are advancing towards the company’s goal to create the future market leader in the treatment of nail fungus. I look forward with confidence to the first approval, which is expected later this year.
Anna Ljung, CEO of Moberg Pharma
ABOUT THIS INFORMATION
This information is information that Moberg Pharma is Obliged to make public persuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below, at 8.00 a.m. CET on May 9th, 2023.
FOR ADDITIONAL INFORMATION
Anna Ljung, CEO, Phone: +46 70 766 60 30, e-mail: anna.ljung@mobergpharma.se
Mark Beveridge, VP Finance, Phone: +46 76 805 82 88, e-mail: mark.beveridge@mobergpharma.se
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