Lipidor AB (publ) publishes interim report for second quarter 2022

Summary of interim report

In May, it was announced that half of the patients had been recruited to Lipidor's Phase lll study with AKP02, the company's skin spray for mild to moderate psoriasis. The last patient started their treatment in July 2022 and in August it was announced that all patients have completed treatment. Topline results from the Phase lll study are expected towards the end of the third quarter of 2022.

Lipidor in brief

Lipidor AB (publ), Org. Nr. 556779-7500 is a Swedish limited company based in Stockholm. The company address is: Lipidor AB, Svärdvägen 13, 182 33 Danderyd.

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.

In 2019, the subsidiary Emollivet AB was formed, with a focus on veterinary care products based on Lipidor’s formulation platform AKVANO®.

Significant events during the second quarter (Apr-Jun)

• On 20th May, it was announced that half of the patients had been recruited to the Phase III study with AKP02 cutaneous spray for mild to moderate psoriasis. Topline results from the study are expected during the third quarter of 2022.

Significant events during the reporting period

• On 26th January 2022, it was announced that the first patients have been enrolled in a Phase III clinical trial with AKP02 cutaneous spray (calcipotriol + betamethasone dipropionate 0.005% / 0.05%) for mild to moderate psoriasis. The study will be conducted during the first half of 2022.
• On 3rd March 2022, it was announced that the subsidiary Emollivet AB will launch COMBI – an antiseptic emollient spray for horses with pastern dermatitis. The product is released on the Swedish market and is available for purchase since 3rd March via Emollivet's e-commerce site www.emollivet.se
• On 15th March 2022, it was announced that the subsidiary Emollivet AB is conducting a financing round and recruiting key people. The new share issue, which is a rights issue to existing owners, amounts to SEK 5 million. Lipidor has subscribed for its share of the issue volume, an investment of SEK 2.92 million.

Significant events after the reporting period

• On 1st July, the Board of Directors resolved to grant a total of 162,500 employee stock options to the participants in the long-term performance-based incentive program LTI 2022:1 for employees of the company, as decided by the 2022 Annual General Meeting.

  Furthermore, it was resolved to grant 427,115 warrants to Lipidor AB within the framework of the long-term performance-based incentive program LTI 2022:1 for employees of the company decided by the 2022 Annual General Meeting.

  Based on the assumption that all options included in LTI 2022:1 are vested, an assumed share price of SEK 10 upon exercise of the options or synthetic options and an assumed average percentage for social security contributions of approximately 31.42 percent, the total costs of the program, including social security contributions, are estimated to amount to approximately SEK 4.3 million.

  LTI 2022:1 shall comprise a maximum of nine employees and consultants in Lipidor. The program runs for three years and means that the participants are granted employee stock options free of charge that entitle them to acquire shares in Lipidor at a subscription price corresponding to the share's quota value. LTI 2022:1 also gives participants the opportunity to choose to be partially granted synthetic options that entitle them to cash remuneration instead of shares.

• On 11th July, it was announced that the last patient had been included in the ongoing Phase III study with AKP02 for mild to moderate psoriasis. The recruitment is thus complete.
• On 23rd August, it was announced that all patients included in the company's Phase III study with AKP02 have completed treatment. This means that the data can be compiled and then analyzed.

Statement from Lipidor’s CEO

The year began at a high tempo, and during the second quarter we continued to maintain a high level of activity, with the main focus on our ongoing Phase III clinical study with AKP02 for the treatment of psoriasis. The study includes a total of 294 patients, distributed across 15 participating clinics in India. In July, we announced that the last patient had been included in the study and that recruitment was thereby complete. In August, we confirmed that all participants had been processed, which means that the data can be compiled and then analyzed.

The study compares the therapeutic effect, against mild to moderate psoriasis, of the sprayable drug candidate AKP02 with Enstilar, a commonly prescribed preparation in foam form, which contains the same combination of active substances as AKP02. The primary goal of the study is to show good therapeutic effect for the treatment of mild to moderate psoriasis, on both the body and the scalp. Among the secondary objectives, the Phase III study also measures perceived quality of life and patient satisfaction to demonstrate associated patient benefits. Results from the study are expected in the third quarter of 2022.

A positive result from the Phase III study with AKP02 is the most important remaining milestone before commercialization in accordance with the license agreement we signed in the summer of 2021 with RELIFE S.r.l. for Europe, the CIS countries and Turkey. Our assessment is that the prospects for a positive outcome in the study are good. According to the agreement, Lipidor will also be able to generate license income from product sales of both AKP01 and AKP02. RELIFE focuses on dermatological indications and products, and is part of the leading international pharmaceutical concern, Menarini Group.

AKVANO® – validated technology platform

With Lipidor's patented formulation technology AKVANO®, well-proven drugs, whose patent period has expired or will expire, can be reformulated and improved with regard to effect, side effects and ease of use (so-called super generics). We can conclude that our activities and achieved milestones have validated the AKVANO® technology. Today, AKVANO® has both medical proof-of-concept (the Phase III study with AKP01) and commercial proof-of-concept (the license agreement with RELIFE). During the year, we have also started compiling a series of scientific articles about the technology. So far, there are publications about AKVANO® in the reputable journals Pharmaceutics and the European Journal of Pharmaceutical Sciences. Overall, this contributes to a stronger negotiating position and product portfolio. The objective is to enter into several commercial agreements on priority markets in the coming years.

Phase III study results this autumn

The positive development of the projects has so far gone according to our established plans, thanks to a small, unique, and highly experienced and skilled team which together constitute one of Lipidor's most important strengths. We are well on our way to taking the big step from being a development company to becoming a growth company that generates revenue. This is something that I am personally extremely proud of.

This autumn will be intense and exciting, and we look forward to presenting the upcoming results from the Phase III study.

Stockholm, 24th August 2022

Ola Holmlund

CEO

Lipidor AB

Financial Calendar

Interim report Q3 (Jan-Sep) 2022 23rd November 2022

See the interim report

Interim report Q2 2022 (Swedish)

Publication

The information was provided for publication by Lipidor’s CEO on 24th August 2022 at 8.30 am (CEST).