Year-end Report 1 January to 31 December 2018
Summary of the year-end report
Financial year (1 January to 31 December 2018)
- Operating revenue KSEK 1 (0)
- Income after financial items KSEK -15 434 (-8 824)
- Earnings per share -0,41 (-0,50)
- Cash and cash equivalents as of 31 December 2018 KSEK 38 716 (33 357)
- Equity ratio as of 31 December 2018 93,2 (90,4) %
Fourth Quarter (1 October to 31 December 2018)
- Operating revenue KSEK 1 (0)
- Income after financial items KSEK -4 534 (-3 231)
- Earnings per share -0,12 (-0,18)
Significant events during the fourth quarter of 2018
- The company completed the rights issue of units approved at the Extraordinary General Meeting on October 1, 2018. The rights issue was subscribed to 90 percent. Approximately 36 percent of the issue was subscribed by unit rights, approximately 4 percent of the issue was subscribed without unit rights and approximately 50 percent was subscribed by issuers. Through the rights issue, Cyxone's share capital increases by SEK 1,339,097.65 through the issue of 17,743,034 shares. Following the rights issue, the company's share capital amounts to SEK 2, 826,983, while the number of shares will amount to 37,457,517. Through the rights issue the company will receive approximately SEK 44.3 million before issue costs.
- The company has selected the clinical site that will carry out the drug candidate T20K's first in man study. The clinical site located in Western Europe has been carefully evaluated based on a number of crucial criteria and will treat the first healthy volunteers in the clinical phase 1 study for T20K developed for the treatment of multiple sclerosis (MS).
- The preclinical program for drug candidate T20K in multiple sclerosis (MS) has been concluded following positive results in the toxicology studies. The drug candidate T20K has now shown to be safe to give to humans and the next step is to test the effect of T20K in clinical trials.
Significant events after the end of the period
- The United States Patent and Trademark Office has issued U.S. Patent 10,159,710 B2 - a divisional patent related to the already approved 'parent patent' for drug candidate T20K in development for the treatment of multiple sclerosis (MS).
- The Disciplinary Committee at Nasdaq Stockholm decided to impose disciplinary sanctions on the company for violation of Nasdaq First North regulations. The Disciplinary Committee instructs Cyxone to pay the stock exchange a fine of SEK 200,000, corresponding to two annual fees as a result of violations regarding the rules of the regulations for disclosure of insider information during the second half of 2017.
CEO Kjell Stenberg comments
2018 has been a year where we have taken several important business and development steps forward and the patients whose lives we envisage being able to improve have felt increasingly present in our work.
During the fourth quarter, the company completed a financing round, initiated preparations ahead of Rabeximod's phase 2b study and documented significant characteristics of T20K. At the same time, the ever present and important dialogue continued with pharmaceutical companies and investors interested in Cyxone’s technology and projects.
T20K and MS
Cyxone has, during the quarter, continued the studies aimed at characterizing and documenting T20K and its effects in preparation for administrating the substance to humans for the first time when clinical phase 1 is initiated. In addition to the information that we previously have found, we have now also clarified how T20K can affect the animal at repeated, higher, doses. This work is particularly important when working with a substance that remains in select organs for a period of time in the way that T20K accumulates in the immunologically active organs of the small intestine and spleen. Other important activities that have been ongoing simultaneously are the development of the bioanalysis methodology and the preparations for the manufacturing of the sterile ampoules that are to be used in the clinical study.
Rabeximod and RA
The contribution of capital that the third-quarter rights issue entailed has made it possible for Cyxone to initiate the work on the studies that are included in Rabeximod’s new phase 2b-program. As previously announced, Cyxone’s acquisition of Rabeximod included all information that the previous owner OxyPharma needed to be able to carry out their previous phase 2 study, as well as all the data and results from this clinical study in patients with moderate to severe RA. This information will certainly make Cyxone’s work significantly easier in comparison to taking an entirely new substance through phase 2. However, since the planned new clinical study will treat patients for twice as long as the previous one, Cyxone must conduct additional animal studies with the substance in order to demonstrate Rabeximod’s safety over 24 weeks of treatment.
Cyxone is following up on the contacts in both pharma companies and among investors that the company has initiated in order to lay the foundation of a favorable commercial development of the company and of our respective candidates.
Finally, I would like to thank our shareholders for your continued, and in relation to the rights issue renewed, trust. Your tireless support and commitment have been and remains a major asset for us at Cyxone, which is why we look forward to together with you continue to bring our candidates forward closer to commercial development.
Follow our news and information about our presence at investment events via Nasdaq First North and the company's website: www.cyxone.com
CEO, Cyxone AB
Upcoming financial reports and annual general meeting
April 2, 2019 Annual report 2018 will be published on the Cyxone Webpage
May 17, 2019 First quarter report
May 24, 2019 Annual Shareholder’s Meeting
August 28, 2019 Half year report
November 15, 2019 Third quarter report
February 14, 2020 Year-end report 2019
February 14, 2019
The Board of Directors
This is a translation of the original Swedish version of the interim report. In case of any discrepancy between this translation and the Swedish original, the latter shall prevail.
Cyxone AB (publ)
Kjell G. Stenberg, CEO
Tel: +46 (0) 723 816 168
221 22 Malmö
This report contains such information that Cyxone AB is required to make public under the EU’s Market Abuse Regulation. This Information was submitted by CEO Kjell Stenberg for publication on February 14, 2019.
This press release contains forward-looking statements that constitute subjective estimates and forecasts about the future. Assessments about the future are only valid on the date they are made and are, by their nature, similar to research and development work in the biotech field, associated with risk and uncertainty. In light of this, actual outcomes may differ substantially from what is described in this press release.
Cyxone AB is a clinical stage biotech company with a portfolio of immunomodulating drugs for the treatment of autoimmune diseases such as multiple sclerosis (MS) and rheumatoid arthritis (RA). The company’s drug portfolio is based on two technological pillars in the form of oral molecules and cyclotide-based drugs that inhibit key processes in the body’s cells that are typically associated with various immune-related disorders. Cyxone’s technologies have the potential to address an unmet need and provide new effective and safe medicines that can improve the quality of life for patients affected by autoimmune diseases. The company has two drug candidates, T20K for MS in a preclinical program and Rabeximod for RA in clinical phase II-program. Cyxone’s Certified Adviser on the Nasdaq First North is Mangold Fondkommission AB which can be reached by telephone 08-503 015 50 and e-mail email@example.com. www.cyxone.com