Cyxone comments on decision on the penalty from the Disciplinary Committee at Nasdaq Stockholm
Cyxone (publ), a Swedish biotech in autoimmune diseases, announced today that the Disciplinary Committee at Nasdaq Stockholm has 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.
For the decision in its entirety, reference is made to Nasdaq Stockholm's website and also the company's own website.
On December 6, 2018, the surveillance function at Nasdaq Stockholm submitted a case to the Disciplinary Committee at Nasdaq Stockholm, where the Disciplinary Committee was asked to examine whether Cyxone on September 28, 2017 had violated the stock exchange regulations and, if so, to establish reasonable sanctions. On February 6, 2019, at 18:00 CET, the Disciplinary Committee announced that it had decided on the matter. For its part, the Disciplinary Committee noted that Cyxone has failed to notify market impacting information in contravention of Nasdaq First North's regulations, section 4.1, i.e. disclosure of insider information, in connection with a CEO presentation at the event BioStock Live on September 28, 2017. Cyxone's CEO, Kjell G. Stenberg, according to the Disciplinary Committee's interpretation, stated that the company's intention was to apply to the Swedish medicines agency Läkemedelsverket for a merger of a completed so-called Phase 2 study of the company's drug candidate Rabeximod with a previous Phase 2 study to achieve the regulatory requirements for a drug approval, which is sometimes referred to as a Phase 3 study. According to the Disciplinary Committee's interpretation, this means that the company intends to deviate from the usual order during clinical trials and that this intention constitutes insider information.
Cyxone's comment on the decision
Cyxone respects the views expressed by the Disciplinary Committee at Nasdaq Stockholm but disputes the claim that the company has failed by disclosing insider information. The company believes that the regulatory framework for drug development is generally known information and thus publicly available. Moreover, according to the company's opinion, there is no "usual order" for drug development, but the "usual order" must be based on the case in question.
The CEO's account of the possibility of merging data from the two so-called Phase 2 studies is, according to the company, an account of current rules and that the information is thus not insider information. That the company intends to work in accordance with the applicable regulations is, according to the company, neither insider information. This is because such information according to the EU Market Abuse Regulation (MAR) must state the circumstances or events that have been sufficiently specific to enable conclusions to be drawn about the potential impact of the information on the company's share.
Kjell G. Stenberg, CEO of Cyxone, commented, "I am, of course, very disappointed with the Disciplinary Committee's decision but respect its views. In this case, however, we are of a different opinion than the Disciplinary Committee and we maintain that the information that was disclosed in connection with the CEO's presentation does not constitute insider information, but only aimed at explaining the possibilities within the medicines agency’s regulations. In fact, regulations for drug development do not require a specific scheme but look different from project to project.”
This contains such information that Cyxone AB is required to make public under the EU’s Market Abuse Regulation. The information was provided under the auspices of the above contact person for publication on February 07, 2019.
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, +46 (0)8-503 015 50, firstname.lastname@example.org. www.cyxone.com