Interim Report 1 January to 30 September 2022

Financial Summary for the group

Significant events during the third quarter of 2022

• Cyxone filed submission to start clinical Phase 2b study in Poland and Georgia
• Cyxone received regulatory approval to start clinical Phase 2b study in Rheumatoid Arthritis in Poland
• Cyxone appointed Erika Samuelsson as Chief Development Officer
• Ola Skanung will take over the role as CFO from Henrik Hang as of November 2022
   

Significant events after the end of the period

• No significant events
   

CEO Carl-Magnus Högerkorp comments

During the third quarter we continued the preparatory work for the phase 2b trial in rheumatoid arthritis APPRAIS where our current focus lies. The regulatory approval to start the study in Poland was a very important validation which builds confidence around the trial.

Important regulatory approval from the Medical Product authority in Poland

During the summer, in preparation for the planned phase 2b trial, APPRAIS, applications for performing clinical trials were submitted to the authorities and ethics committees in Hungary, Poland and Georgia. In September the medical product authority in Poland (Office for Registration of Medicinal Products, Medical devices and Biocides) approved Cyxone’s application. The approval is a very important step towards the start of the clinical trial and provides considerable confidence in the trial design for APPRAIS.  With a substantial number of patients planned to be enrolled, Poland constitutes as one of the biggest contributors to the trial.

APPRAIS is a 24-week multicentre, randomized, double-blind, placebo controlled, parallel group trial to evaluate the efficacy, safety and tolerability of orally administered Rabeximod in patients with active, moderate to severe rheumatoid arthritis with inadequate response to the current first line treatment methotrexate. The trial will be a cornerstone in the upcoming commercialization activities for Rabeximod in this important therapy area.

New T20K pre-clinical developments show promise

The work on our second asset T20K continues. The current focus on process development aims at establishing a more optimized and cost-effective manufacturing process. The collaboration with the Medical University of Vienna progresses and recent research findings from this work were presented at The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congress in October. New data investigating the synergistic effect between T20K and K-opioid receptor agonists has demonstrated promising results. Furthermore, the work from our collaboration partners in Vienna recently resulted in the further broadening of our understanding of T20K biology with a research article in the scientific journal Biomedicine & Pharmacotherapy indicating that T20K may have an effect on anaplastic large cell lymphoma.

Management team strengthened

Along with our preparation of our clinical activities, we further strengthened the management team of our company and appointed Erika Samuelsson as the new Chief Development Officer (CDO) in September and Ola Skanung as the new Chief Financial Officer (CFO) in August. Both bring many years of experience from a range of listed life science companies and are well acquainted with the needs of development companies in this industry. Both of them will strongly contribute to Cyxone’s growth journey and make a positive impact going forward.

Future outlook

In the past quarter, we have completed a range of activities for the preparation of the planned phase 2b trial along with the continued development of the company. I’m positive and excited about the future and looking forward to receiving further important regulatory approvals from Hungary and Georgia. We are well positioned, with a strong and focused team and an efficient organization, to start the 2b trial APPRAIS and continue creating value for our shareholders. We will also continue to increase our efforts to establish long-term strategic and value creating collaborations with the biotech and pharma industry, as well as with academic institutions. I look forward to keeping you updated on developments of our exciting journey.

Please follow the company's development and receive information about our participation in investor meetings via Nasdaq First North Growth Market and on the company's website, www.cyxone.com

Carl-Magnus Högerkorp
Acting CEO
Cyxone AB

Upcoming financial reports

17 February 2023             Year-end report 2022

The report is enclosed in full here, and all reports will be available from these dates at www.cyxone.com

Submission of interim report

Malmö
October 27, 2022
The Board of Directors
Cyxone AB

Disclaimer

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.

Contact

Carl-Magnus Högerkorp, Acting CEO
Tel: +46 (0)70 781 88 12
E-mail: carl.hogerkorp@cyxone.com

The information was submitted for publication, through the agency of the contact person set out above, at 08.30 a.m. CEST on 27th of October 2022.

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.

About Cyxone

Cyxone AB (publ) (Nasdaq First North Growth Market: CYXO) develops disease modifying therapies for diseases such as rheumatoid arthritis and multiple sclerosis. Rabeximod is a Phase 2 candidate drug being evaluated for the management of rheumatoid arthritis. T20K is a Phase 1 candidate drug for treatment of multiple sclerosis. Certified Adviser is FNCA Sweden AB.
Please visit www.cyxone.com