Interim Report January 1st to June 30th, 2019
Summary of the interim report
First Half year (January 1st to June 30th, 2019)
- Operating revenue KSEK 0 (0)
- Income after financial items KSEK -9 129 (-6 503)
- Earnings per share -0,24 (-0,37)
- Cash and cash equivalents as of 30 June KSEK 23 872 (17 817)
- Equity ratio as of June 30th 94,3 (92,8) %
Second Quarter (April 1st to June 30th, 2019)
- Operating revenue KSEK 0 (0)
- Income after financial items KSEK -4 366 (-3 755)
- Earnings per share -0,12 (-0,21)
Significant events during the second quarter of 2019
- In May, the registration of Cyxone Switzerland AB was initiated, a wholly-owned subsidiary in Basel, Switzerland. This subsidiary is important for the company’s global presence.
- In May, the application was submitted for initiation of the First in Human, phase I, clinical trial for the drug candidate T20K, which is under development for treatment of multiple sclerosis (MS).
- In June, a First in Human, phase I, study with T20K was commenced in male healthy volunteers after the Dutch authorities’ fast approval of Cyxone’s preparatory work for the clinical studies.
Significant events after the end of the period
- In July, an application was submitted to the Central Ethics Committee (CEC) in Poland for permission to start a clinical phase IIb study with the drug candidate Rabeximod, which is under development for the treatment of rheumatoid arthritis (RA). Applications in up to eight additional European countries will follow in the next six months with recruitment start planned for H1 2020.
- In July, the first male healthy volunteer was administered with the lowest dose of T20K in First in Human, phase I study.
- In July, the clinical research organization (CRO) EGeen Inc. was signed to carry out the upcoming clinical phase IIb study with Rabeximod in selected Eastern European countries. The CRO Sourcia manages the study in Western Europe.
- In August, positive top line results from the T20K clinical phase I study were reported, which successfully achieved its goal of confirming T20K’s safety and tolerability in humans. There were no reports of serious side effects in this infusion study.
CEO Kjell G. Stenberg comments
The second quarter of the year was marked by Cyxone’s step into the clinical development phase with both its candidates, T20K that is under development for multiple sclerosis (MS) and Rabeximod for rheumatoid arthritis (RA). We were pleased to announce good results from T20K’s First in Human trial, discussions with potential stakeholders as well as the first submission to start a phase II study in Rabeximod’s development program.
A successful phase I study for T20K
The drug candidate T20K is originally derived from the naturally occurring substance Kalata B1 and had previously only been tested in various animal species before being accepted by the Dutch authorities for human testing.
With years of preparatory studies as a base, the First in Human study, also known as a phase I study, could be initiated in May. The study, which can be considered one of the company’s major milestones, could be carried out with a positive outcome where the objective was to show that a certain amount of free T20K substance circulating in the blood does not cause unwanted effects in humans. With the knowledge that a significant amount of T20K can be circulating in the blood without causing side effects in humans, we have a very good starting point for the continued development of an oral form administration of T20K. Also, an oral form of administration is not expected to result in such high levels of T20K in the blood, which strengthens the safety profile of the substance and gives the patients a quality of life-enhancing treatment alternative.
Initial start signal for Rabeximod’s phase II study
The work has been intensified with applications to start a multicenter clinical phase IIb study with Rabeximod in patients with RA. An important part of this has been to determine the study design, which we did in consultation with our clinical expert Prof. Désirée van der Heijde and our statisticians to ensure the optimal conditions for a successful phase IIb study. Our knowledgeable partners in the process are pushing forward and during the period, we have continued to supplement the bigger information package, which will also be sent to the different regulatory authorities in both Western and Eastern Europe. The Eastern European countries in particular are very advantageous for Cyxone’s studies in that the use of biological drugs for RA is relatively small in these countries, which is an exclusion criteria for our phase IIb study. A larger possible patient pool facilitates a lot, especially in the recruitment stage, and my personal experience is that clinical research in Eastern Europe is at least as good as the rest of Europe or the US.
Our first submitted application received a positive feedback from the authorities, which validates the fact that our documentation is spot on as well as the team is well prepared for this study.
Strategic expansion to new expanses
Cyxone’s Board has decided to establish a wholly-owned subsidiary in Basel, Switzerland, in a major step towards increasing the company’s exposure not only to continental American and Asian pharmaceutical companies, but also to long-term investors. With the new subsidiary as a base, Cyxone will awaken both investors and drug representatives’ interest in Cyxone and our drug candidates.
We are aiming for a future with better treatments for those affected by severe autoimmune diseases. Thank you for your support and the commitment you show Cyxone on the way!
Follow our news and information about our presence at investment events via Nasdaq First North and our website at: www.cyxone.com.
Malmö 28 August 2019
CEO, Cyxone AB
Upcoming financial reports
November 15th, 2019 Interim Report Quarter 3, 2019
February 14th, 2020 Year-end Report, 2019
Submission of interim report
August 28, 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
211 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 August 28, 2019 at 08.30 CET.
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 clinical phase I-program and Rabeximod for RA in clinical phase II-program. Cyxone’s Certified Adviser on the Nasdaq First North is Mangold Fondkommission AB, telephone +46 (0)8-503 015 50 and e-mail firstname.lastname@example.org. www.cyxone.com