Statement from Lipdor´s CEO
During the fourth quarter, the focus has been on preparations for the planned clinical Phase III study with the combination drug AKP02G2 for the treatment of psoriasis. On 20th December, an application for study approval was submitted to the Indian Medical Products Agency, which is an important step in the project plan. The assessment is that the drug candidate has significant market potential and the commercial interest was confirmed during the quarter with the positive news that our commercial partner Menarini/RELIFE is behind the project. In addition, the collaboration was expanded to include the Asian market. With the agreement with Menarini/RELIFE, Lipidor has entered into license agreements covering approximately 75% of the global market, which is estimated at SEK 9 billion. In October, it was also announced that Lipidor, through a patent application, has the potential to extend the protection of the combination preparation until 2043. In addition, intensive work has been carried out for a suitable financing solution, and short-term financing has been provided to the company through the sale of Emollivet shares and through a loan.
The year as a whole
In 2023, Lipidor’s operations were reshaped in terms of focus and organization. The reason for the operational changes was the study results announced at the end of 2022. At that time, it was announced that our clinical Phase III study for the psoriasis candidate AKP02 did not meet the criterion of equivalent therapeutic effect. As a result, Lipidor’s strategy underwent a major change, including both technical and operational considerations. The retake that was subsequently made was primarily based on the understanding of what needed to be adjusted in the formulation to achieve a positive study result.
The company’s ability to obtain bridge financing for the reformulation work that needed to be carried out was of the utmost importance. Through the divestment of ownership in subsidiaries, the possibility of bridge loans and renegotiated terms with partners, space was created to work towards another Phase III study with generation two of AKP02 (AKP02G2). Decisive efforts were made during the year by several partners, owners, the Board of Directors and management to create the conditions for continued operation and value development in the company.
At the end of the third quarter, a new formulation, a project plan with procured key suppliers and a financial advisor were in place, and the conditions for financing the company were considered to be quite good.
Financing
Lipidor is still aiming for a financing round that will take the company through study implementation and up to a study result. There is a strong commitment from existing major shareholders and, to all intents and purposes, the underlying conditions for a successful capital raise should be in place. Unfortunately, we need to be humble in the face of the fact that today’s financial market is challenging, especially in combination with a significantly lower company valuation than before and the outcome of a financing process is not a given.
At the time of writing, we are continuing to work on finding a financing solution. The hope is that more people will want to invest in the company’s vision and that the project’s intended results will reach the market and, thereby, contribute to an improved everyday life for many patients.
Stockholm, 28th February 2024
Ola Holmlund
CEO