Lipidor AB (publ) publishes interim report for third quarter 2022
STOCKHOLM, Sweden, 23 November 2022 – Today, Lipidor AB (publ) (Nasdaq First North Growth Market: LIPI) publishes its interim report for the period January – September 2022.
The report is available on the company's website lipidor.se and in the attached pdf.
Summary of interim report
During the period, the company conducted a Phase III study from start to finish with AKP02, the company's drug candidate for mild to moderate psoriasis. On October 28, it was announced that significant results can be inferred compared to placebo but that therapeutic equivalency with the reference product was not reached. Continued work is underway to realize the value of the AKP02-project. The board of directors has begun the work of financing the next phase of the business.
|Q3 (Jul-Sep) 2022||Reporting period (Jan-Sep) 2022|
|Net sales 0 KSEK (15 270)
Operating income -12 224 KSEK (3 384)
Result per share prior to and after dilution SEK -0.42 (0.12)
|Net sales 0 KSEK (15 376)
Operating income -32 496 KSEK (-9 348)
Result per share prior to and after dilution SEK -1.12 (-0.33)
|Selected financial data||2022 Jul-Sep||2021 Jul-Sep||2022 Jan-Sep||2021 Jan-Sep||2021 Jan-Dec|
|Net sales, KSEK (thousand kronor)||–||15 270||–||15 376||15 376|
|Operating income, KSEK||-12 224||3 384||-32 496||-9 348||-21 384|
|Income after tax, KSEK||-12 197||3 456||-32 425||-9 276||-21 291|
|Total assets, KSEK||24 948||61 692||24 948||61 692||55 020|
|Cash flow for the period, KSEK||-6 850||6 418||-32 666||-4 759||-12 996|
|Cash flow per share (SEK)||-0.24||0.23||-1.13||-0.17||-0.46|
|Cash, KSEK||18 641||59 544||18 641||59 544||51 307|
|Result per share prior to and after dilution (SEK)||-0.42||0.12||-1.12||-0.33||-0.75|
|Shareholder’s equity per share (SEK)||0.40||1.91||0.40||1.91||1.50|
|Equity ratio, %||46.66%||88.15%||46.66%||88.15%||79.11%|
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 animal skincare products based on Lipidor’s formulation platform AKVANO®.
Significant events during the third quarter (Jul-Sep)
- 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 approved by the Annual General Meeting 2022 for employees in the company. Furthermore, it was resolved to grant 427,115 warrants to Lipidor AB.
- 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.
- On 23rd August, it was announced that all patients included in the company's Phase III study with AKP02 had been fully treated, meaning that the data could be compiled and then analyzed.
- On 25th August, it was announced that Charlotta Ekman had been appointed new CFO of Lipidor. In the role as CFO, Charlotta will also be part of Lipidor's management team. She took office on 1st October.
- On 29th September, it was announced that the company's schedule for the Phase III study with AKP02 for the treatment of psoriasis had been updated and that the company was expected to be able to present the study's topline results during October.
Significant events during the reporting period
- On 26th January 2022, it was announced that the first patients had 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 was to be conducted during the first half of 2022.
- On 3rd March 2022, it was announced that the subsidiary Emollivet AB was to launch COMBI – an antiseptic emollient spray for horses with pastern dermatitis. The product is available for purchase via Emollivet's e-commerce site www.emollivet.se
- On 15th March 2022, it was announced that the subsidiary Emollivet AB was conducting a financing round. The new share issue, a rights issue to existing owners, amounted to SEK 5 million. Lipidor subscribed for its share of the issue volume, an investment of SEK 2.92 million.
- On 20th May, it was announced that half of the patients were enrolled in the Phase lll study with AKP02 skin spray for mild to moderate psoriasis.
Significant events after the reporting period
- On 7th October, it was announced that Lipidor's subsidiary Emollivet AB, which earlier this year launched Emollivet COMBI – an antiseptic emollient spray for horses with mug, rasp and scab – had reached the milestone of selling 1,000 products. The company is now preparing for scaled-up production to meet the high demand.
- On 28th October, it was announced that the company's Phase III study showed that AKP02 had clearly better efficacy than placebo in the treatment of psoriasis. The study's primary goal of achieving equivalent therapeutic efficacy compared to the reference product was however not reached.
- On 15th November, the company gave an update regarding the study outcome. The company's assessment is that AKP02 still has significant potential, and the goal is to continue to realize that value. Intensive work is underway to investigate the conditions for this, which includes strategy and financing.
Statement from Lipidor’s CEO
During the third quarter, the main focus was on our clinical Phase III study with the combination drug AKP02 for the treatment of psoriasis. After the end of the period, on 28 October, we announced that the study did not achieve the criterion of equivalent therapeutic efficacy in the treatment of psoriasis compared to the market-leading reference product.
However, the study results show that AKP02 has a good effect in comparison to placebo and there is support for claiming efficacy on par with other psoriasis products. Our assessment is that AKP02 still has significant potential, and the goal remains to realize that value. Intensive work is underway to investigate the conditions for the way forward, including strategy and financing.
Ongoing dialogue with RELIFE
Dialogue continues with our commercial partner RELIFE, a company in the Menarini Group, which has taken note of our conclusion that both the AKVANO® technology and the specific formulation in AKP02 work also stand well in comparison with other psoriasis products. The discussions include regulatory and market considerations.
Confidence in AKVANO®
I would like to emphasize that we continue to have high confidence in our formulation platform AKVANO®. We base this on the fact that, among other things, the Phase III study of the psoriasis candidate AKP01 showed positive results. It is also gratifying that we were recently able to submit a priority application to the European Patent Office (EPO) regarding an expansion of the AKVANO® platform.
In addition, the subsidiary Emollivet has launched its second skincare product for animals and this shows that AKVANO® technology is ideally suited for these applications. Sales have developed positively during the period and Emollivet is preparing an upscaled production.
Portfolio with multiple programs and significant market potential
Lipidor's Board of Directors is investigating various options to finance the company's continued operations and the work around AKP02. The Board's opinion is that the project portfolio includes several programs with significant market potential and thus great values. This applies, among other things, to the program in the acne area and other projects where the company has or is looking for partners.
Despite the setback with the Phase III study of AKP02, I remain optimistic. We are now looking ahead and solid work is underway on strategy, business plan, costs and financing. We work with a solution-oriented and fact-based approach, with the goal of taking advantage of the company's opportunities and realizing the value of the project portfolio in the best way.
I would like to thank all long-term shareholders, partners, and employees for their continued support.
Stockholm, 23rd November 2022
|Year-end report 2022||22 February 2023|
|Annual report 2022||April 2023|
|Interim report January – March 2023||11 May 2023|
|Interim report January – June 2023||23 August 2023|
|Interim report January – September 2023||22 November 2023|
See the interim report
The information was provided for publication by Lipidor’s CEO on 23 November 2022 at 8.30am (CET).