Statement from Lipdor´s CEO

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