Lipidor AB (publ) publishes interim report for Q2 2024

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

Summary of second quarter

Lipidor has carried out crucial activities ahead of the clinical Phase III study with the company's drug candidate (AKP02G2) for the treatment of psoriasis, with the goal of presenting study results in Q1/25. During the period, production of clinical trial material has been completed and preparations for the upcoming study start are underway together with the company's CRO.

During the quarter, a rights issue was carried out that provided the company with approximately SEK 38 million before issue costs. Together with the co-investment agreement signed with Cerbios-Pharma SA of SEK 12.4 million, financing was secured to carry out the Phase III study with AKP02G2.

Lipidor in brief

Lipidor AB (Nasdaq First North Growth Market: LIPI) (www.lipidor.se) develops medicinal products for the treatment of skin diseases with a focus on psoriasis by reformulating well-proven medicinal substances. With the lipid-based and patented formulation technology AKVANO®, Lipidor aims to develop medicines that have at least an equivalent effect to the leading original product, but which have the clear patient benefits of being quick-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 Q2 (Apr–Jun)

• On 10th April, 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 is entered into.
• Lipidor AB held an Extraordinary General Meeting in Stockholm 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.
• 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. The rights issue was secured to approximately 65.5 percent through subscription commitments and underwriting. The number of shares thus increased from 28,976,863 to 788,170,675 shares. Dilution amounted to approximately 96.3 percent. Upon full exercise of all warrants, the number of shares will increase to 977,969,128, corresponding to an additional dilution effect of approximately 19.4 percent.
• 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 during 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 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.
• On March 21, it was announced that approval for the start of a clinical Phase III study with the company's drug candidate (AKP02G2) for the treatment of psoriasis had been received from the Indian Medical Products Agency (DCGI).

Significant events after the reporting period

• On July 1, it was announced that the company had carried out a directed share issue to underwriters in connection with the completed rights issue. The subscription price in this compensation issue was set at SEK 0.05 per share, corresponding to the subscription price per share in the rights issue, and payment was made by set-off of the guarantors' claims. A total of SEK 1,261,650 is offset in connection with the compensation issue. Through the compensation issue, the number of shares in Lipidor increases by 25,233,000 shares, from 788,170,675 shares to 813,403,675 shares, and the share capital increases by SEK 50,466.00, from SEK 1,576,341.35 to SEK 1,626,807.35, corresponding to a dilution effect of approximately 3.1 percent.
• On August 20, 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.

Statement from Lipidor’s CEO

Dear Shareholders,

I hope you have all had a wonderful summer!

Lipidor's focus is on advancing our drug candidate for psoriasis, AKP02G2, through a Phase III study. This drug candidate is a so-called supergeneric, in the form of a fast-drying spray, which we are confident will provide significant patient benefits. We are very pleased that the raising of capital in the second quarter went well, and the company is now funded to conduct the clinical trial with AKP02G2.

During the quarter, important investments were made in the clinical program for AKP02G2, which were initially possible partly through a credit facility of SEK 3 million from Fenja Capital (formerly Formue Nord) and partly through ongoing invoicing to Cerbios-Pharma SA under the signed co-investment agreement. After net proceeds from the rights issue were received by the company, the credit facility was repaid as well as the previously raised bridge loan from Råsunda Förvaltning AB. Lease fees for GMP-compliant production equipment have also been settled. The company's cash and cash equivalents and the co-investment from Cerbios-Pharma correspond to the financing needed to carry out the study and provide us with a study result in Q1-2025.

Together with our manufacturing partner (CMO), we have manufactured both active trial material and placebo of AKP02G2, and developed the necessary analytical methods. We have also purchased the product that we have chosen to compare with in the upcoming clinical study. As previously announced, we will compare our drug candidate with LEO Pharma's Enstilar, which is the market leader for the treatment of mild to moderate psoriasis and has an attractive pricing.

Enstilar is the same product that was used in the clinical study of AKP02G2's predecessor AKP02, with results presented in October 2022. Unfortunately, the goal of non-inferiority was not achieved in that study. Since then, we have put considerable effort into identifying and implementing the improvements required in the new version, to ensure optimal conditions to achieve the study objective. This is crucial for our commercial partner, Menarini, to be able to register and ultimately market a drug based on Lipidor's development.

Recently we announced that study material has been sent to our CRO (Clinical Research Organisation) which means that we are keeping to the established schedule, and the material will now be distributed to the clinics in India. The work of initiating and training the staff who will run the study has begun and instructional material has been produced to ensure that Lipidor's quick-drying spray is used correctly by the patients included in the study. We aim for the first patient to start their treatment at the end of September. We will follow the study closely and ensure that resources are available to answer any questions from our CRO during the work. It will be an incredibly exciting time ahead of the study results!

In addition to the study, discussions are being held with licensees in those areas that are not covered by our agreement with Menarini. Above all, the focus is on South America and the Nordic region. The ambition is to move forward in some of these conversations and to create more attractive revenue opportunities for Lipidor. I look forward to updating you as the work progresses.

Stockholm, 28th August 2024

Ola Holmlund

CEO

Financial Calendar

Lipidor has decided to shift from quarterly reporting to half-yearly reporting.

See the interim report

To read the Q2 report (in Swedish) click here: https://lipidor.se/investors/financial-reports/

Publication

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