Lipidor publishes interim report for Q3 2020
Summary of the interim report – third quarter 2020
A quarter of high activity and many important milestones, including: a directed share issue of SEK 35 million, a new share issue and CEO recruitment in the subsidiary Emollivet, key agreement signed for the start of planned Phase III study with AKP02 and continued positive data from a joint feasibility study with Cannassure.
|Net sales 0 KSEK (0)
Operating income -4 915 KSEK (-3 831)
Result per share prior to and after dilution (SEK) -0,21 SEK (-0,19)
|Net sales 455 KSEK (0)
Operating income -10 715 KSEK (-9 370)
Result per share prior to dilution -0,25 SEK (-0,49)
Significant events during the third quarter (Jul-Sep)
- On 7th July, we announced that an agreement has been entered into with Cadila Pharmaceuticals, a leading Indian pharmaceutical company with extensive CRO capacity, to conduct a Phase III study with Lipidor's drug candidate AKP02. The study is expected to begin in Q1 2021 and be finalized in Q1 2022.
- On 7th July, we announced that the subsidiary Emollivet AB had recruited Stina Linge as CEO.
- On 10th July, we announced that Lipidor has signed an agreement with OY Medfiles Ltd. for the delivery of clinical trials for the Phase III study with the drug candidate AKP02 for Psoriasis.
- On 11th September, it was announced that Lipidor had completed a directed new issue amounting to SEK 35.0 million before issue costs amounting to SEK 2.0 million.
- On 30th September, a positive outcome from the company's feasibility study was published in collaboration with Cannassure Therapeutics Ltd., for the development of medical cannabis based on the company's AKVANO® technology.
Significant events during the reporting period (Jan-Sep)
- On 24th January, we announced positive results from the company's clinical phase III study of calcipotriol spray (AKP01) for psoriasis.
- In January, we announced that the Knowledge Foundation is funding collaborative projects for studies of how drug formulations affect the skin barrier. In collaboration with Malmö University, MediGelium AB, Larodan AB and ERCO Pharma AB, Lipidor has been granted research grants from the Knowledge Foundation for a joint project. The project extends over two years and aims to develop models and investigate how body-specific ceramides and other lipids can be used to create more effective formulations of dermatologicals and facilitate repair of damaged skin. The project comprises a total budget of SEK 4.6 million, of which SEK 0.7 million is co-financed by Lipidor through research initiatives.
- On 16th March, we announced that Aurena Laboratories AB has developed and launched a disinfectant spray in collaboration with Lipidor, based on Lipidor's AKVANO® technology, sales of which began in March and generated commission income from April.
- On 7th May, Lipidor submitted an updated project plan and announced, among other things, the intention to initiate a self-funded phase III study concerning AKP02.
- On 30th June, it was announced that Lipidor and its subsidiary Emollivet AB have formalized their relationship by entering into a license agreement that regulates Emollivet's right to Lipidor's patented AKVANO® technology in the veterinary medicine area.
- In light of the outbreak of the coronavirus and COVID-19, Lipidor is closely monitoring the development of events and taking measures to minimize the impact on the company's operations. Lipidor follows guidelines from the Swedish Public Health Agency, WHO and ECDC (European Center for Disease Prevention and Control). To date, COVID-19 has had a limited effect on Lipidor's operations, but the company may need to revise its schedules if the pandemic is prolonged.
Significant events after the reporting period
- On 1st October, it was announced that Anders Hagman had been recruited as CDO.
- On 7th October, it was announced that Lipidor has appointed Erik Penser Bank AB as Certified Advisor
- On 14th October, it was announced that the subscription price was set at SEK 9.95 for the company's warrants (of series T01 2019).
- On 11th November, it was announced that the subscription period expired on 3rd November, with the result that approximately 95.9 percent of the options were exercised for subscription of shares. Through the subscription, Lipidor will thus receive approximately SEK 20.0 million. Through the exercise of the warrants, the number of shares in Lipidor increases by 2,012,863 shares, from 26,384,000 to 28,396,863 shares. The share capital increases by SEK 100,643 from SEK 1,319,200 to SEK 1,419,843.
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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
Lipidor's vision and goal is to establish the company's patent-protected drug delivery technology AKVANO® as the leading formulation platform in the development of dermatological pharmaceutical. Just over a year ago, on September 27, 2019, Lipidor took the step into the stock market and Nasdaq First North Growth Market.
Since then, we have announced several important news that confirm our development plan timeline.
Important milestone achieved
We are very pleased with the positive outcome of the feasibility study development of topical (on the skin) medical cannabis products for the treatment of skin inflammations including psoriasis. It is an important milestone as the study results showed that cannabinoids can be incorporated into our innovative formulation platform. The study was conducted in collaboration with our partner Cannassure Therapeutics, which has announced that it intends to exercise its option and begin negotiations on an exclusive licensing agreement. The common goal is to introduce innovative topical treatments on the fast-growing global market for medical cannabis. We look forward to continued successful cooperation and our assessment is that the collaboration with Cannassure can have significant commercial potential for Lipidor.
Continued focus on outlicensing
The positive study result from the phase III study with our most advanced drug candidate, AKP01, for the treatment of psoriasis is a validation of our platform technology. The validation means that we can accelerate the pace of development in several other areas. The market has also shown interest in our other drug candidate, AKP02. By financing the implementation of the upcoming phase III study with AKP02, we keep the whole upside when outlicensing the project. We see a great potential to discuss both product candidates in a package as this makes us an even more attractive partner for pharmaceutical companies who can take our products through registration to sale. Discussions with potential licensees are ongoing and we stick to our goal to be able to enter into commercial agreements regarding AKP01 and AKP02 within the next six months. Both drug candidates are for the treatment of psoriasis which is a chronic disease and affects between 2–3 percent of the world's population.
Planning for the phase III study with AKP02
Key agreements are in place with the companies (CRO and CMO) that will carry out the phase III study with the drug candidate AKP02 and produce test materials. An intensive work is going on around the details of the study. We maintain a close dialogue with our partners and we take measures to minimize the risk of possible delays due to the ongoing pandemic. However, we stick to the goal of initiating the study in early 2021.
Continued high pace
During the quarter, a directed issue of SEK 35 million was carried out, which created prerequisites for accelerating Lipidor's growth journey and opportunities for commercial collaborations. The subscription period for the company's outstanding warrants (of series TO1 2019) expired on 3 November, and 95.9 percent of the options were exercised, which during November brought in approximately SEK 20.0 million. On October 1, Anders Hagman took on the newly created role of Chief Development Officer in the company's management team. Anders' solid experience and competence in drug development will complement the organization in a valuable way. As a consequence of the COVID-19 pandemic, we have to some extent adapted our work processes. With a committed, highly specialized and experienced Lipidor team as well as dedicated international industrial partners, it is gratifying to note that our projects continue to develop according to plan. We are optimistic and our intention is to maintain a continued high pace in the business.
Stockholm, 19 November 2020
At the Annual General Meeting on 11th June 2020, the Board members Fredrik Sjövall, Ola Flink and Gunilla Lundmark were re-elected. New election of members Denis Angioletti and Otto Skolling. Fredrik Sjövall was appointed chairman.
Gabriel Haering and Per Nilsson resigned from the board.
At the Annual General Meeting, PwC was re-elected with Magnus Lagerberg as the company's auditor.
At the Extraordinary General Meeting on 11th August, there was a unanimous decision on the approval of the subsidiary Emollivet AB's decision on the new share issue and on the approval of Emollivet's decision on a long-term incentive program.
Year-end report 2020 23rd February 2021
Annual report 2020 Published on the company’s website w/c 19th April 2021
Quarterly report January–March 6th May 2021
Annual General Meeting 8th June 2021
The information was provided for publication by Lipidor’s CEO on 19 November 2020 at 8.00am (CET).