Interim Report 1 January to 31 March 2019
Summary of the interim report
First Quarter (1 January to 31 March 2019)
- Operating revenue KSEK 0 (0)
- Income after financial items KSEK -4 762 (-2 747)
- Earnings per share -0,13 (-0,15)
- Cash and cash equivalents as of March 31st KSEK 30 049 (27 227)
- Equity ratio as of March 31st 95,9 (90,6) %
Significant events during the first quarter of 2019
- The US Patent and Trade Mark Office (USPTO) approved patent 10,159,710 B2 - a partial patent, known as a "divisional patent", relating to the previously approved 'original patent' for the T20K drug candidate developed for the treatment of multiple sclerosis (MS).
- Pre-clinical findings support the positioning of the T20K drug candidate as a prophylactic agent for the treatment of MS. This suggests that the substance could be used for early intervention in MS, which would mitigate or prevent MS relapses and potentially could even delay progression of the disease. No other available treatment currently seeks to address early intervention in this way.
Significant events after the end of the period
- There were no significant events after the end of the period.
CEO Kjell G. Stenberg comments
During the first quarter of 2019, Cyxone laid the foundations for the two upcoming clinical studies of our candidates T20K for MS and Rabeximod for rheumatoid arthritis (RA). Having finished 2018 with strong pre-clinical results for T20K and a capital injection ear-marked for the continued development of Rabeximod, the company now anticipates further clinical development work with these substances and thereby demonstrate their potential as drug treatments.
T20K and MS
In March, Cyxone announced that pre-clinical data supported the positioning of T20K as a prophylactic agent for MS. This means that T20K could be given to patients at the time of diagnosis, which could slow progression of the disease and thereby push back patients’ subsequent MS relapses and potentially alleviate these symptoms, something that would substantially improve patients’ quality of life. Cyxone is currently concluding the preparatory studies necessary to guarantee the safety of T20K in a so-called Phase 1 or “First-in-Human” study where the drug will be administered by injection.
Rabeximod and rheumatoid arthritis
During the quarter, Cyxone prepared for a Phase 2b study intended to confirm Rabeximod’s efficacy on patients with moderate to severe RA. The company has held discussions with a number of laboratories in its planning work ahead of conducting a 24-week safety study on Rabeximod in two types of animals. We have also evaluated and selected manufacturers that will fill capsules with Rabeximod under GMP (good manufacturing practice) conditions and held discussions with several clinical study organisations regarding conducting a Phase 2b study. All this is designed to ensure that the Phase 2b study has the best possible opportunities to replicate Rabeximod’s strong results previously observed in a Phase 2 study after 16 weeks’ treatment.
In addition to our clinical development programmes, during the first quarter Cyxone also met potential co-operation partners, buyers and investors for the company’s two development substances. These meetings have been made possible, in part, by the company visiting a raft of industry and partnering events such as BioEurope in Vienna and Drug Discovery Summit in Barcelona.
Finally, I would like to extend my thanks to shareholders who have tirelessly supported Cyxone throughout our development work. Our candidates have the potential to transform both treatment and perception of MS and RA. We are working hard to take their development forward to ultimately offer patients a better quality of life than is currently possible.
Follow our news and information about our presence at investment events via Nasdaq First North and our website at: www.cyxone.com.
CEO, Cyxone AB
Upcoming financial reports and annual general meeting
May 24th, 2019 General Meeting
August 28th, 2019 Interim Report Quarter 2, 2019
November 15th, 2019 Interim Report Quarter 3, 2019
February 14th, 2020 Year-end Report, 2019
Submission of interim report
May 17, 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 May 17, 2019 at 08.30 CET.
This report 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 report.
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, telephone +46 (0)8-503 015 50 and e-mail email@example.com. www.cyxone.com