Statement from Lipdor´s CEO
Lipidor has been working at a high pace towards the goal of carrying out a new Phase III for our psoriasis candidate AKP02G2. Recently, we announced the positive news that our commercial partner Menarini/RELIFE stands behind our venture. We have now agreed on an addendum agreement with new timelines in which we also expand our collaboration to include the Asian market. With this agreement, we have entered into licences that cover approximately 75% of the global market, which we estimate to be SEK 9 billion. This is of course excellent news and strengthens our case considerably. In October, we also announced that a patent application with the potential to extend the protection of AKP02G2 had been filed. Overall, both the commercial reach and the potential time window work to the company’s advantage.
We have continued to refine and define our updated business plan in order to present a compelling future for Lipidor to investors. With Menarini/RELIFE by our side and previously entered into agreements with CRO and CMO, we have the agreements required to be able to conduct a Phase III study.
The new study is planned to be conducted in India and largely according to similar study protocols as the previous study, where we missed the target by only a small margin. The purpose of the study will be to evaluate the efficacy, safety and equivalence of the updated formulation AKP02G2 in comparison to the same market-leading product as last time. As previously announced, we have developed an improved formulation that we consider to have great chances of meeting the overall study goal. With knowledge and experience from the Phase III study conducted in 2022, we have been able to make important changes to our formulation that will help create a more similar effect profile compared to the original drug.
There are several factors that bode well for Lipidor
- In our assessment the new improved formulation of AKP02G2 has great potential to meet study goals.
- The psoriasis market is growing steadily and we do not see that the competition will change significantly in the foreseeable future.
- AKVANO® as a formulation provides substantial patient benefits that increase the possibility for Menarini/RELIFE to gain significant market share. AKP02G2 dries quickly and doesn’t smudge compared to ointments and creams.
- We now have a commercial agreement in place that covers approximately 75% of the global world market.
We are humbled by the fact that today’s financial market is challenging, and it will take both perseverance and creativity to bring financing to a successful conclusion. A couple of years ago, the company’s progress, together with the verified value chain and plans in place, had created good conditions for financing the next step of the business. Today, as many have experienced, the situation is different and despite operational progress according to plan, the outcome of a financing process is not self-evident.
On behalf of the management team and the Board of Directors, we have developed an operational plan that should be attractive to you as an investor. To get to the next step in the process, we are now working together with our financial advisor to reach one or two anchor investors who can provide the conditions deemed necessary in today’s market climate.
Lipidor is a very interesting company with a clear focus on a large and growing market.
Stockholm, 22 November 2023