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

Summary

During the year, Lipidor has passed significant milestones. A new share issue during the second quarter of 2024 has enabled the company's ongoing clinical Phase III study with the psoriasis candidate AKP02G2.

Significant milestones are the completion of clinical trial material, initiation of the Phase III clinicial trial with AKP02G2 and implementation and planning of regulatory efforts. Results from the Phase III study with AKP02G2 are expected in April 2025 according to the previously communicated plan.

Lipidor in brief

Lipidor develops drugs for the treatment of skin diseases, with a focus on psoriasis, through the reformulation of well-proven drug substances. With the lipid-based and patented formulation technology AKVANO®, Lipidor intends to develop drugs that have at least equivalent effect to leading original products, but which provide the clear patient advantage of being quicker-drying and easier to apply (sprayable) compared to existing products on the market.

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.

Significant events during the second half-year (Jul-Dec)

• On 1st July, it was announced that the company had carried out a directed share issue to guarantors in connection with the completion of the rights issue. Through the compensation issue, the number of shares in Lipidor will increase by 25,233,000 shares, corresponding to a dilution effect of approximately 3.1 percent.
• On 20th August, the company announced that the clinical trial material for the Phase III study with AKP02G2 had been released according to plan and that it had been shipped to the company's CRO.
• On 24th September, the company announced that the first patient had been enrolled in the Phase III study with AKP02G2.
• On 3rd December, the Nomination Committee was presented, for which Jan Poulsen has been appointed Chairman.

Significant events during the reporting period

• On 24th January, it was announced that one of the company's patents had been sold. The sale was aimed at strengthening Lipidor's cash position in the short term. In March, it was announced that the remaining ownership in Emollivet had been divested for the same reason.
• On 21st March, it was announced that approval for the start of a Phase III clinical trial with the company's drug candidate (AKP02G2) for the treatment of psoriasis had been received from the Indian Medicines Agency (DCGI).
• On April 10, it was announced that Lipidor resolves on a rights issue of approximately SEK 58 million and that a co-investment agreement of SEK 12.4 million has been signed. A credit facility of SEK 3 million has been signed.
• Lipidor AB held an Extraordinary General Meeting on 21st May 2024. The AGM resolved to approve the Board of Directors' resolution on a new issue of units, consisting of shares and warrants of series TO 2, with preferential rights for the shareholders.
• On 24th May, a prospectus was published in connection with the rights issue.
• On 5th June, Lipidor’s Annual General Meeting was held. The AGM resolved to authorize the Board of Directors to issue shares as part of a guarantee commission and to reduce the share capital.
• On 13th June, the outcome of the rights issue was announced. Approximately 37.6 percent of the rights issue was subscribed for with and without the support of unit rights. However, the Rights Issue was secured to approximately 65.5 percent through subscription commitments and underwriting commitments.
• On 25th June, it was announced that the rights issue, as well as the share capital reduction resolved at the Annual General Meeting, had been registered with the Swedish Companies Registration Office. After the registration of the rights issue and the share capital reduction, the number of shares in the company amounts to 788,170,675 shares and the share capital amounts to SEK 1,576,341.35. The quota value thus amounts to SEK 0.002 per share.

Significant events after the reporting period

• On 21st January, the company announced that half of the patients in the ongoing Phase III trial for the drug candidate AKP02G2 have been randomized in the clinical study. The forecast shows results in April 2025.

Statement from Lipidor’s CEO

It is an exciting and crucial period for Lipidor, as we are now approaching the publication of the results from our ongoing Phase III study.

Second half of the year

During the second quarter, we were able to announce that we had successfully completed a successful refinancing of the company with the aim of being able to conduct a new Phase III study of the updated drug candidate AKP02G2. The focus for the second half of 2024 has been to start the clinical study according to the ambitious timetable that we set together with our new CRO partner, Cliantha Research.

In September, the first patient was recruited to the study, and after a somewhat slow start-up, patient recruitment accelerated significantly towards the end of the year. It is particularly gratifying that almost all patients screened for the study also qualify for participation. We are now in the final phase of recruitment and will announce to the market when the study is fully recruited.

Phase III clinical trial

The purpose of the ongoing clinical trial is to compare the therapeutic effect of our sprayable and quick-drying drug candidate in patients with mild to moderate psoriasis, with a market-leading preparation. The study, which includes 294 patients, and is conducted in India, aims to generate the results that will enable Lipidor's license partner, Menarini/RELIFE, to register and launch a drug.

After this year's new share issue, the company has many new shareholders, including a new major shareholder in the form of Life Science Invest Fund. It is gratifying and important that another committed and long-term owner has been added. The owner Jan Poulsen has also undertaken to lead the work of Lipidor's Nomination Committee.

Future prospects

In parallel with the study, we are preparing for the next step in development, in which the submission of a registration application will be an important milestone. Although Lipidor will not directly submit the application, it is our responsibility to ensure that all necessary documents and activities on our part comply with the regulatory requirements.

In the event of a positive study result, the conditions are in place to be able to register a product together with Menarini/RELIFE that has good conditions to compete with the current market-leading product. AKP02G2's properties complement the existing offering and are considered to provide several important patient benefits.

The company is now at a very crucial stage in the development process, and we look forward to receiving the results that can pave the way for AKP02G2 towards the market.

Stockholm, 28th February 2025

Ola Holmlund

CEO

Financial Calendar

A request to have a matter considered at the Annual General Meeting must be received no later than seven weeks before the Annual General Meeting in order to be included in the notice.

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 2025 at 8.30am (CET).

For more information, please contact

Lipidor AB (Reg. No. 556779-7500)
Ola Holmlund, CEO
Phone: +46 72 50 70 369
Email: ola.holmlund@lipidor.se
c/o Ekonomistubben
Box 55931
102 16 Stockholm

Certified adviser

The company’s Certified Adviser is Carnegie Investment Bank AB (publ)
Phone: +46 (0)73 856 42 65
Email: certifiedadviser@carnegie.se

About Lipidor AB

Lipidor AB (www.lipidor.se) is a Swedish, Stockholm-based research and development company with a pipeline of pharmaceutical development projects in preclinical and clinical phases. 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.