Lipidor AB (publ) publishes interim report for Q3 2023

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

Summary of interim report

Lipidor is working at a high pace towards the goal of conducting a new Phase III for the psoriasis candidate AKP02G2. Recently, it was announced that the company's commercial partner Menarini/RELIFE stands behind the venture 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 third quarter consisted of development initiatives as well as strategy and financing work. Lipidor signed an agreement with Cliantha Research for the implementation of the planned Phase III study for the treatment of psoriasis. Given funding, recruitment of patients will begin in the first half of 2024.

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.

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

Significant events during the third quarter (Jul-Sep)

• On 20th September 2023, Lipidor AB announced that it has signed an agreement with Cliantha Research to conduct a phase III study with the drug candidate AKP02G2, for the treatment of psoriasis. The study is expected to start recruitment of patients in the first half of 2024 and we hope to be able to present study results as early as December of the same year.

Significant events during the reporting period

• On 17th 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.
• On 26th 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 22nd June, Lipidor announced that the Swedish Medical Products Agency had 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 29th 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 after the reporting period

• On 18th October, it was announced that a new agreement had been reached with RELIFE regarding the company's psoriasis project. The new terms relate to geographic expansion through the addition of the Asia-Pacific region and an updated timeline. Lipidor has previously signed a license agreement in which Lipidor grants RELIFE exclusive rights to register, market, distribute and sell drug candidates for the treatment of psoriasis in Europe, the CIS countries and Turkey. The new agreement extends the geographical scope of the license to the Asia-Pacific region. The parties also agree on an updated timeline where the goal is to take the updated second generation of the company's combination formulation for psoriasis through a phase III study in 2024.
• On 27th October, it was announced that the company had filed a new patent application with the European Patent Office (EPO). The patent originates from the development that took place during the reformulation work with AKP02, now AKP02G2. With the new patent application, AKP02G2 and a number of other applications of the technology (subject to approval by the patent authorities) will be patent protected until 2044.

Statement from Lipidor’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.

Financing

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

Ola Holmlund

CEO

Financial Calendar

See the interim report

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

Publication

The information was provided for publication by Lipidor’s CEO on 22 November 2023 at 8.30am (CET).