Lipidor

To read the year-end report (in Swedish) click here: https://lipidor.se/investors/financial-reports/

Summary of fourth quarter

Lipidor is working towards the goal of carrying out a new Phase III for the psoriasis candidate AKP02G2. During the autumn, it was announced that the company's commercial partner Menarini/RELIFE is behind the initiative and is expanding its collaboration with the Asian market. License agreements thus cover approximately 75% of the global market for AKP02G2.

Operational work during the fourth quarter consisted of development initiatives as well as strategy and financing work. Lipidor, together with Cliantha Research, applied to the Indian Medical Products Agency for approval of the planned Phase III study for the treatment of psoriasis.

Lipidor in brief

Lipidor AB (publ), Org. Nr. 556779-7500 is a Swedish limited company based in Stockholm. The company address is: Lipidor AB, c/o Ekonomistubben, Box 55931, 102 16 Stockholm.

Lipidor is a drug development company with a pipeline of drug development projects in the preclinical and clinical phase. The company can develop topical medical products for the treatment of skin diseases such as psoriasis, acne vulgaris, bacterial skin infections and atopic dermatitis by reformulation of proven pharmaceutical substances. The company's priority project is called AKP02G02 and focuses on psoriasis.

Significant events during the fourth quarter (Oct-Dec)

• On 18th October, it was announced that a new agreement had been reached with RELIFE regarding rights to register, market, distribute and sell drug candidates in the company's psoriasis project. The new terms relate to geographic expansion through the addition of the Asia-Pacific region, and an updated timeline with the goal of taking the company's combination formulation for psoriasis through a Phase III study in 2024.
• On 27th October, it was announced that the company has filed a new patent application with the European Patent Office (EPO) regarding AKP02G2. Subject to approval, AKP02G2 and a number of other applications of the technology will be patent protected until 2043.
• On 30th November, it was announced that the company was changing its Certified Adviser from Erik Penser Bank AB to Carnegie Investment Bank AB (publ).
• On 5th December, the company presented its Nomination Committee, which will consist of four members.
• On 20th December, it was announced that the company, through its partner Cliantha Research, has submitted an application to the Indian Medical Products Agency to start a Phase III study with the drug candidate AKP02G2 regarding topical treatment of mild to moderate plaque psoriasis.
• On 21st December, it was announced that 63 shares, corresponding to approximately SEK 0.5 million, have been divested in the associated company Emollivet and that a loan of approximately SEK 0.6 million has been raised from the company's largest shareholder Cerbios-Pharma SA.

Significant events during the reporting period

• On 17th January 2023, Lipidor held an Extraordinary General Meeting in Stockholm. At the Annual General Meeting, a resolution was passed approving the transfer of shares in the subsidiary Emollivet AB to two major shareholders in Lipidor. In February 2023, 653 shares out of the Parent Company's 1,243 shares were sold.
• On 26th May, Lipidor announced that it had decided to pursue a new Phase III study with AKP02G2 in 2024.
• On 22nd June, Lipidor announced that the Swedish Medical Products Agency assesses that AKP02G2, the modified version of the company's drug candidate AKP02 for the treatment of psoriasis, can be used in a new clinical Phase III study.
• On 29th June, Lipidor AB announced that financing of SEK 2 million would be provided through the sale of its holding in the associated company Emollivet. A short-term loan of SEK 1 million has also been signed, of which SEK 0.5 million has been provided to the company at the end of the reporting period.
• On 20th September 2023, it was announced that Lipidor AB has signed an agreement with Cliantha Research to conduct a Phase III study with the drug candidate AKP02.

Significant events after the reporting period

• On January 24, it was announced that one of the company's patents, which was previously out-licensed to Emollivet AB, has now been sold to the same party. The sale aims to strengthen Lipidor's cash position in the short term.

Statement from Lipidor’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

Financial Calendar

See the year-end report

To read the year-end report (in Swedish) click here: https://lipidor.se/investors/financial-reports/

Publication

The information was provided for publication by Lipidor’s CEO on 28th February 2024 at 8.30am (CET).