Lipidor publishes interim report for Q1 2021

Summary of the interim report – first quarter 2021

The period began with a signed license agreement with Cannassure Therapuetics Ltd, regarding medical cannabis products based on Lipidor's AKVANO® technology. Activities prior to the start of the Phase III study with AKP02, and increased focus on discussions with potential licensees of the drug candidates AKP01 and AKP02 for the treatment of psoriasis.

Significant events during the first quarter (Jan-Mar)

• 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. Lipidor will receive double-digit royalties from upcoming product sales as well as a milestone payment for a certain sales volume achieved up to a maximum of €350,000 EUR.

Significant events after the reporting period

• On 22^nd April, Lipidor published an update on the planned clinical phase III study with the company's drug candidate AKP02 for the treatment of psoriasis.
• On 23^rd April, it was announced that Lipidor's subsidiary Emollivet AB had taken the next step towards launch and received a grant of SEK 300,000 from Vinnova.

Selected financial data

Lipidor in Brief

Lipidor AB, Org. Nr. 556779-7500 is a Swedish limited company based in Stockholm. The company address is: Lipidor AB, Fogdevreten 2, 175 21 Solna.

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, bacterial skin infections and atopic dermatitis.

In 2019, the subsidiary Emollivet AB was formed, with a focus on veterinary care products based on AKVANO.

Statement from Lipidor’s CEO

We now enter a new stage of development for Lipidor having made significant progress in several areas. The first quarter began with positive news that the company has entered into a licensing agreement with Cannassure Therapeutics Ltd. The licensing agreement stipulates that Cannasure is granted exclusive rights for use of Lipidors unique formulation platform AKVANO® in their medicinal cannabis products for psoriasis, atopic dermatitis, pain and wounds. The license agreement is important external validation of Lipidor’s unique formulation platform demonstrating that also cannabionoids may be incorporated in AKVANO®. The external validation is inspiring as it is in line with our vision to establish AKVANO® as a leading formulation platform in development of skin pharmaceuticals. 

We are very pleased with the agreement which is also a significant commercial milestone. The license agreement is an important step toward our general goal to enter into commercial cooperation to create income based on milestone payments and royalties on future sales. We have great faith in Cannassure and high expectations in the partnership which has the goal for the medicinal cannabinoids to reach the market as quickly as possible.

Licensing continues to be priority No. 1

Lipidor is firmly established with two pharmaceutical candidates in late clinical stage, ready for licensing. The out-licensing of the drug candidates AKP01 och AKP02, both for psoriasis, is our top priority. We have for some time conducted extensive negotiations with potential licensees, discussions which have deepened during the quarter, and which are continuing to date. 

It is most promising that the market has shown considerable interest for both AKP01 and AKP02. We see continuous great potential for our initial drug candidate AKP01, and the possibility to out-licence both AKP01 and AKP02 as one package is in our estimation an advantage for the licensee at registration and commercialization. Furthermore, we see great advantages in discussing both drug-candidates in one package, as this makes us a more attractive partner for a buyer of the products. The licensee then has the opportunity to bring two supporting products through registration to market which generates synergies.

Another important aspect in discussions with potential licensing partners may be product sourcing, i.e. the licensee’s ability to access large-scale production of the drug candidates in accordance with GMP- and other regulatory requirements. By agreement in December 2020 with Aurena Laboratories AB, one of the two strong industrial major shareholders of Lipidor, Aurena will establish a production facility which will fulfil regulatory requirements for production of AKVANO® based medicines. It is a strategic advantage for us in the ongoing discussions to be able to offer the licensee access to commercial production of the products. 

Phase lll-study in AKP02

Our leading drug candidate AKP01 demonstrated positive results last year in a concluded Phase lll-study. The experiences learned from AKP01 provide hope for a successful study also with AKP02. The Phase lll-study with AKP02 may provide a basis for registration, is under initiation, and will include 294 patients in approximately ten clinics in India. The study will be conducted by Cadila Pharmaceuticals, a leading Indian Pharmaceutical company with extensive CRO capacity. Cadila proved in the previously conducted Phase lll-study with AKP01 that they were able to effectively recruit patients, administer dosing and report clinical findings. The planned study will also monitor quality of life and patient appreciation with the ambition to demonstrate advantages with AKP02 in these aspects. The Phase lll-study is expected to have the initial patient included for treatment during the summer and reporting during the first half of 2022.

Positive trend

In my estimation, we have a sound basis for entering into commercial agreements in the near future whereby we will be able to accelerate Lipidor's growth. I am optimistic and look forward to a continuously exciting year of operations. 

Stockholm, 6^th May 2021

Ola Holmlund

CEO

Financial Calendar

Interim report January-June           24^th August 2021

Interim report January-September  17^th November 2021

Information

The information was provided for publication through the office of Lipidor’s CEO on 6^th May 2021 at 8.00am (CEST).

Lipidor AB delårsrapport Q1 2021