Lipidor AB re-publishes year-end report for 2019

Summary of year-end report – fourth quarter and reporting period 2019

During the fourth quarter, the company's clinical phase III study of the drug candidate AKP01 against psoriasis was completed. The study included 277 randomized patients and was carried out by Cadila Pharmaceuticals in India. After the reporting period, positive results from the study were announced. The study met its primary endpoint, and the AKP01 candidate was well-tolerated. No significant side effects were reported. The positive results are also proof-of-concept for the company's patented drug-delivery technology for topical treatments.

In December, the company announced that an evaluation and licensing agreement had been signed with the Israeli company Cannassure. The agreement gives Cannassure an option to license Lipidor's drug-delivery technology for selected applications in the topical medical cannabis area, if the results of the evaluation studies turn out as expected. The evaluation results are expected during the second half of 2020.

A new share issue amounting to approximately SEK 20 million was carried out during the first quarter, in order to facilitate the continued clinical development of the company’s pharmaceutical products and prepare the company for public listing. The company's shares were listed on the Nasdaq First North Growth Market on 27 September 2019, and the company received approximately SEK 25.2 million before deduction of issue costs, in a listing issue that was oversubscribed.

Statement from Lipidor’s CEO

During the month of January 2020, we were able to announce that Lipidor has achieved the most important milestone in the company's history to date. The completed phase III clinical trial of calcipotriol spray (AKP01), with the goal of evaluating the efficacy and safety of AKP01, achieved its primary treatment goals and demonstrated therapeutic equivalence with the comparison product. AKP01 was very well–tolerated during the eight-week treatment, with a low occurrence of adverse reactions, and no serious adverse events were reported.

The good study result validates AKVANO as a formulation platform. This strengthens our other projects, which are all based on the company's patented lipid-based technology. Previously, the Swedish Medical Products Agency has been open to the opportunity to take AKP02 directly to a phase III study, with the support of a positive result for the now–completed AKP01 study. We will now work to bring AKP02 directly into a phase III study in 2020.

We have continued with a strategic review of upcoming patent expirations of best-selling topical products, where we believe that Lipidor's AKVANO technology could lead to improved products. The company is continuously evaluating possible collaborations, for which it is also being paid.

A major potential value–driver for Lipidor is the evaluation and licensing agreement we entered into with the Israeli company Cannassure in December, for the cannabis category. If the evaluation work goes well, we see significant opportunities to launch products together with Cannassure with active substances from the cannabis plant in an interesting and growing therapy area.

Our subsidiary Emollivet AB, with a focus on veterinary products, conducted the first test production of a skincare series for animals in 2019. With this, the operational activities of the company commenced, and we have several companies who are currently evaluating the products.

In the coming years, Lipidor intends to start several clinical studies with the ambition of concluding development agreements after completed phase II clinical studies. Lipidor has several ongoing discussions about development collaborations.

Stockholm, 25 February 2020

Ola Holmlund

CEO

Significant events during the fourth quarter (Oct-Dec)

• In the beginning of November, the last patient completed treatment in the company’s phase III study
• On 10 December 2019, we reported that Lipidor and Cannassure Therapeutics Ltd (“Cannassure”) had signed an agreement for a feasibility study and an option to license the development and sale of topical medical cannabis products. The collaboration commenced with an evaluation of the feasibility of incorporating active pharmaceutical ingredients from the cannabis plant in Lipidor’s proprietary drug delivery platform technology AKVANO. 

Significant events during the reporting period (Jan-Dec)

• During December 2018 and January 2019, the company carried out a new share issue totaling SEK 20.0 million
• In June 2019, Lipidor formed the subsidiary Emollivet AB for commercialization of veterinary products
• The company's shares were listed on Nasdaq First North Growth Market on 27 September
• The new share issue in September 2019 brought in approximately SEK 25.2 million before deduction of issue costs

Significant events after the reporting period

• On 24 January 2020 we reported positive results from the company’s phase III clinical study of calcipotriol spray (AKP01)against psoriasis.
• In January 2020 we reported that the Knowledge Foundation is funding a collaborative project to study the effects of drug formulations on the skin barrier. Lipidor, in collaboration with Malmö University, MediGelium AB, Larodan AB and ERCO Pharma AB, has been awarded a research grant from the Knowledge Foundation for a joint project.
• No other significant events have occurred after the reporting period.

See the year-end report

Year-end report 2019 (Swedish)

Information

The information above was provided by Lipidor AB (publ) according to EU Market Abuse Regulations. The information was provided, through the below contact person, for publication on 25 February 2020 at 8.00am CET.

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