Hello, and welcome to Moberg Pharma Q3 report for 2021. Throughout the call, all participants will be in listening-only mode, and afterwards, there will be a question and answer session. Today, I am pleased to present CEO Anna Ljung. Please begin your meeting.
Thank you, and hello, everyone. My name is Anna Ljung. I'm the CEO of Moberg Pharma, and with me today, I also have our VP of Finance, Mark Beveridge. We're happy to present the Q3 report that was published this morning. You can find the report on our website, and there you will also find a PowerPoint presentation that I will use throughout this call. I'll start on page three on that presentation. Just giving that overview of Moberg Pharma. We're a Swedish pharmaceutical company that base our products on drug delivery of known substances, which reduces time to market and development risk compared to traditional drug development.
Our lead program is MOB-015 against nail fungus, and here we see that we have the possibility to become the global market leader within onychomycosis, targeting a global sales potential of $250 million-$500 million on an annual basis. We're currently preparing to file for registration in EU based on the outcome of the two large Phase 3 studies that we completed with more than 800 patients. In these studies, we met the primary endpoint, and 76% of patients were fungus-free, mycological cure, and that is higher than ever reported for an external treatment and on par with oral treatments. We're targeting filing this autumn, and based on average processing time of one and a half years, we expect approval early 2023, which would enable launch by the end of 2023.
We do have commercial partnerships in place with strong partners in major territories, including Bayer for Europe, Taisho for Japan, DongKoo for Korea, Cipher for Canada, and we actually yesterday announced one additional partnership with Allderma for Scandinavia. It's not the first time we're launching our onychomycosis product. We do have a proven commercial track record with our first-generation product, Kerasal Nail, where we sold more than 50 million units and built a SEK 440 million franchise. We learned a lot during the commercialization process of this first-generation nail fungus product. The goal here is to use the lessons learned and build business that has even greater potential and targeting becoming the future market leader in nail fungus.
On page four, our main activities during this quarter have been focused on the approval process, and one major milestone that we achieved was that we received approval for the pediatric plan from EMA. I will talk more about that, but we also secured partnerships with Allderma for the Scandinavian countries. Further on, we have started to work with preparation for the next Phase 3 study that will take place in the U.S. We also strengthened the management team with Agneta Larhed, who has broad experience within regulatory issues and drug development, including working with the Swedish MPA and companies such as Orexo and [Humana.]
Finally, the Swedish tax authorities published a notification of allocation of acquisition costs after the spin-off of Bupi through the distribution of shares in OncoZenge to our shareholders and the successful listing of OncoZenge on Nasdaq First North Growth Market earlier this year. Of that original acquisition cost of shares in Moberg Pharma, 88% is allocated to remaining shares in Moberg and 12% to the distributed shares in OncoZenge. Let's talk a little bit more about our EU approval process and this received approval for the pediatric plan from EMA, and I'm now on page five, where we, in September, received this positive decision that enables us to pursue a full MAA with data exclusivity in Europe for up to 10 years after first market approval, complementing our existing patent protection in all major markets up to 2032.
We will initiate such a pediatric study during the second half of 2022 on 30 children aged between 6 - 17 years. We have until 2026 to finalize this study. We intend to submit the MAA application through a decentralized process, and we're now in discussions with several regulatory authorities on the possibility of serving as a reference country and also when they can process our application based on their current workflow. Our goal remains to submit the registration for adults before the end of this year. That would enable expected approval early 2023 and launch by the end of 2023.
Turning to page six. Yesterday, we announced a new collaboration covering Sweden, Denmark, and Norway with Allderma, which is a Swedish pharmaceutical company that sells and markets OTC drugs and personal care products in Scandinavia. Allderma is actually managed by the same persons which were responsible for the original Nordic launch of Nalox, our first generation nail fungus product. In this collaboration, Allderma is responsible for marketing and sales, while we're responsible for manufacturing and delivery of the product. This agreement also includes co-financing our marketing activities and market-based financial terms. When Nalox was launched in Sweden, it quickly became the market leader and grew the market by 400% during the first quarter.
We're really excited about and look forward to repeating this successful cooperation and see a great benefit in being directly involved in the launch of MOB-015 in our home market. This aspect gets us closer to consumers, pharmacists and doctors and gets us a genuine understanding on how the product works for the patient. We can thus develop best practices prior to the continued launches with our partners globally. If I turn to page seven, for the U.S., we're planning for one additional study for the registration. It will be very similar to the North American study that we already completed, but with a shorter dosing regimen, enabling even stronger change and higher complete cure. In addition to enabling U.S. approval, this additional study is expected to strengthen things globally, substantially increasing market potential.
The risk in this new study is significantly reduced through using the experience gained in the previous study, and we will actually work with the same CRO, and we will have the same principal investigator, Professor Gupta from University of Toronto, as in that previous North American study. Of course, we will reuse both sites that were successful and so on. It's a de-risked new study that we're planning to start early next year. Our goal is to submit the documentation on this new study to the FDA and to ethics committee during the first quarter of next year. Moving on to the financial part of the report, on slide nine. Sorry, slide eight, you see our financials. I would say, as usual, our expenses are in line with the previous period.
We continue to invest in the MOB-015 development, which is capitalized. Given that we are in registration phase, those investments are limited. Due to the Bupi spin-off in OncoZenge, and that's the IPO that followed, we have a positive earnings effect of SEK 24 million in total profit this year. In the beginning of this year, we also completed the SEK 150 million rights issue. That means that we're currently well-funded with financing in place for both registration activities and for the clinical development. Thus, we can fully focus on our operations. Our current cash position is SEK 111 million. Turning to page nine, to summarize, we do have an exciting journey ahead.
The next milestone is the EU submission before year-end, as well as preparations for the new U.S. study, where we plan to submit documentation during this first quarter next year. I think these milestones are very important, and we expect to create significant value as they enable both the launch in EU by the end of 2023 and commercialization in the U.S., the largest and most important market, as well as strengthening the sales globally. These are key steps in our journey to make MOB-015 the future market leader in [many silos.] Basically, taking that overall picture, I think we're making progress gradually towards our goal, and we continue to deliver according to plan. This was a rather short summary of what has happened in this quarter.
Thank you for listening in, and I'm happy to open up for questions if there are any.
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Thank you. I just want to thank everyone for listening in. Of course, if you have additional questions, I'm available over phone or email, and Mark as well. I just wish you, everyone, a good day.