To read the quarterly report (in Swedish) click here: https://lipidor.se/lipidor-ab-delarsrapport-q2-2023/

Summary of interim report

The operational work has consisted of both development efforts, primarily linked to the company's drug candidate AKP02G2, as well as strategy and financing work. During the period, short-term financing was secured through agreements regarding the sale of shares in the associated company Emollivet and the securing of loans.

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 develops drugs 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.

In 2019, the associated Emollivet AB was formed, with a focus on animal skincare products based on Lipidor’s formulation platform AKVANO®.

Significant events during the second quarter (Apr-Jun)

• On 26 May, Lipidor announced that it has set its sights on a new Phase III study with AKP02 in 2024 after analysing data from the previously conducted clinical study with the drug candidate AKP02. AKP02 was very close to achieving equivalent therapeutic effect with the reference product in the study conducted in 2022. An in-depth analysis of why the effect of the different preparations differed has resulted in an explanatory model that is now undergoing a verification programme.
• On 22 June, Lipidor announced that the Swedish Medical Products Agency assessed 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. This means that no further clinical studies with AKP02G2 will be needed before a new Phase III study can be initiated.
• On 29 June, Lipidor AB announced that financing of 2 MSEK is provided through the sale of holdings in the associated company Emollivet. A short-term loan of 1 MSEK has also been signed, of which 0.5 MSEK has been provided to the company at the end of the reporting period.

Significant events during the reporting period

• On 17 January 2023, Lipidor held an extraordinary general meeting in Stockholm. The meeting resolved to approve that the company transfers shares in the subsidiary Emollivet AB to two major shareholders in Lipidor. In February 2023, 653 shares of the parent company's 1,243 shares were sold.

Significant events after the reporting period

• Payment for the agreed divestment of 274 Emollivet shares was received in July.

Statement from Lipidor’s CEO

After last year's setback, we have worked intensively on evaluating, defining, and developing an updated business plan for Lipidor. Work has continued during the second quarter of the year, and with the support shown by the operational management, the Board of Directors, and our largest owners, for our formulation technology and the great potential we see in our main project AKP02, we aim to conduct a new Phase III study as soon as possible. It also means that we will put our entire focus on AKP02G2 (generation two of AKP02) and thus prioritize that all the conditions are in place for the new study as soon as possible.

We have gained a lot of experience and knowledge from the Phase III study carried out in 2022. Based on these lessons we have been able to make important changes in our formulation, which should help create an effect profile that is more comparable to the original drug.

There are several strong arguments for focusing on AKP02G2:

• There is a large and growing market for an improved formulation of the lead product for the treatment of mild to moderate psoriasis, and competition is judged to be limited, based on analysis of ongoing late phase clinical trials.
• We already have a partnership with one of Europe's largest pharmaceutical companies, Menarini/Relife, which includes all of the relevant steps for taking AKP02G2 through registration and launch on the European market.
• We have come a long way in setting up commercial production, and therefore feel confident in our ability to produce products for commercial needs.

Our assessment is that the potential for AKP02G2 is better now than when the previous Phase III study was initiated. With our new insights, the conditions for achieving positive results are likely to improve, and with this as a starting point, our agreement with Menarini/RELIFE needs to be updated. The dialogue around this is ongoing, in a positive spirit.

New Phase III study

The aim of the study will be to evaluate the efficacy, safety and equivalence of the updated formulation AKP02G2 in comparison with the same market-leading product as last time. The study design will include patients with mild to moderate psoriasis and the evaluation of effect will also take place in the same way as in the previous study. We have also held a meeting with the Swedish Medicines Agency and received confirmation of our plan for a new study. Our goal is to deliver the so-called HLR (High Level Results) from the study around the turn of the year 2024–2025.

Financing

Based on the new continuations, the work to finance the next step in the company's development is also intensified. We will provide updates on this shortly and are very confident in the process and we have received very positive feedback so far regarding our focused AKP02G2 approach.

With our new focus, I am convinced that we are on the right track and that the continuation of reaching our high goals is good.

Stockholm, 23 August 2023

Ola Holmlund

CEO

Financial Calendar

See the interim report

Interim report Q2 2023 (Swedish)

Publication

The information was provided for publication by Lipidor’s CEO on 23 August 2023 at 8.30am (CEST).