Lipidor AB (publ) publishes year-end report for 2021

Summary of year-end report

During the year, Lipidor's most important milestone to date was reached when a commercially exclusive agreement for registration, marketing, sales and distribution of AKP01 and AKP02 was signed with RELIFE S.r.l – part of a leading international pharmaceutical company, Menarini Group. In connection with the signing of the agreement, Lipidor received the first milestone compensation amounting to EUR 1.5 million. The potential value of the agreement amounts to at least EUR 70 million.

During the year, Lipidor's AKP02 project was also approved for the initiation of a clinical phase III study against psoriasis, with expected topline results during the second quarter of 2022. Progress is also announced in the collaboration with Cannassure Therapeutics, where positive results led to a new patent application being filed and that the collaboration is taken further towards the clinical phase.

Financial overview for the period

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 Q4 (Oct-Dec)

• The CEO and employees redeemed all warrants during the month of October. Through the exercise, the number of shares and votes in the company increased by 580,000
• On 29^th October, it was announced that Lipidor has filed a new patent application for medical cannabis products based on Lipidor's AKVANO® technology and that the collaboration with Cannassure Therapeutics is being taken towards the clinical phase
• On 17^th December, it was announced that a development program has been launched for a new drug candidate, AKP08, targeting acne vulgaris (acne). The market for prescription drugs for acne is valued at around SEK 35 billion

Significant events during the reporting period (Jan-Dec)

• On 18^th January, it was announced that Lipidor had entered into an exclusive agreement with Cannassure Therapeutics Ltd. in Israel, for medical cannabis products based on Lipidor's AKVANO® technology
• On 23rd April, it was announced that Lipidor's subsidiary Emollivet AB had taken the next step towards launch and received funding of 300 KSEK from Vinnova
• On 1^st July, it was announced that Lipidor has signed a license agreement under which Lipidor grants RELIFE S.r.l., the right to sell AKP01 and AKP02 for the treatment of psoriasis in selected markets
• On 27^th September, it was announced that Lipidor has received approval for the start of a Phase III clinical study of the psoriasis candidate AKP02

Significant events after the reporting period

• On 26th January 2022, it was announced that the first patients have been included in a Phase III clinical trial with AKP02 cutaneous spray (calcipotriol + betamethasone dipropionate 0.005% / 0.05%) for mild to moderate psoriasis. The results from the study are expected during the second quarter of 2022

Statement from Lipidor’s CEO

On July 1, we were able to announce that Lipidor has entered into an exclusive agreement for the registration, marketing, sale and distribution of both the company's psoriasis candidates, AKP01 and AKP02 for the treatment of psoriasis. This is one of the most important milestones to date in Lipidor's history. Our partner, RELIFE S.r.l., is a company with a focus on dermatological indications and products. RELIFE is part of the Menarini Group, which is a leading international pharmaceutical group with headquarters in Italy and global representation in 140 countries. The agreement means that RELIFE takes over responsibility for registering, marketing, distributing and selling psoriasis products in the EU, Turkey, the United Kingdom, Switzerland, the CIS and the Balkans. The potential value of the agreement amounts to at least EUR 70 million, with emphasis on revenues based on forecast sales, but also including one-off payments at milestones achieved. The first payment at the signing of the agreement amounted to EUR 1.5 million.

Our goal is to enter into more agreements regarding AKP01 and AKP02 in other geographical markets and discussions are ongoing with potential partners.

The next major milestone in the collaboration with RELIFE is the clinical phase III study of AKP02 against psoriasis. After approval to start the study in the autumn, we were able to announce on 26 January this year that the first two patients had been included in the study. The study covers a total of 294 patients in 13 participating clinics in India. The trial is fully funded with existing cash. The main purpose of the study is to compare the therapeutic effect of the sprayable drug candidate AKP02 against mild to moderate psoriasis with Enstilar, a commonly prescribed preparation in foam form, which contains the same combination of active substances as AKP02. Our assessment is that the prospects for a positive outcome in the study are good. Results are expected during the second quarter of 2022.

During the fourth quarter, we also filed a new patent application based on the data generated so far within the framework of the collaboration project with Cannassure Therapeutics. Cannassure develops medical cannabis products based on Lipidor's AKVANO® technology.

Lipidor is strongly involved in the development of additional topical drug candidates based on AKVANO® with a continued focus on dermatology. This is a treatment area where we believe that there is a strong demand for products that provide better treatment results and therefore improved patient benefits. In December, we were also able to announce that we have launched a development program for a new drug candidate, AKP08, for the treatment of acne vulgaris (acne). The market for prescription drugs for acne is valued at around SEK 35 billion, which together with the clinical needs relating to acne makes it a very attractive indication to invest in.

Overall, 2021 was a successful year. The milestones achieved during the year have contributed to us as a drug development company significantly reducing the risks in our product portfolio. We will continue to do our utmost, together with our partners, to develop and commercialize products that can contribute to patient health and well-being, as well as the company's growth journey. With the forthcoming results from the ongoing phase III study and the work for new commercial contracts, the company's position will be further strengthened in 2022. Lipidor is today a company that will be able to generate revenue from sales of products relatively soon.

Stockholm, 23^rd February 2022

Ola Holmlund

CEO

Lipidor AB

Financial Calendar

Interim report Q1 (Jan-Mar) 2022                 5^th May 2022

Interim report H1 (Jan-Jun) 2022                  24^th August 2022

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

The Annual Report 2021 will be available on the company's website during April 2022.

The Annual General Meeting will be held on 2^nd June 2022 in Stockholm.

See the year-end report

Year-end report 2021 (Swedish)

Publication

The information was provided for publication by Lipidor’s CEO on 23^rd February 2022 at 8.30 am (CET).

Lipidor AB delårsrapport Q4 2021