Interim Report 1 January to 31 March 2023

Financial Summary for the group

Significant events during the first quarter of 2023

• Cyxone announces the nomination committee's proposal for the AGM and the resignation of two board members.
• Cyxone makes significant progress in the manufacturing process for rabeximod.
• Cyxone receive ethical and regulatory approval from Georgia to conduct clinical Phase 2b study in RA.
• Cyxone advances the patent portfolio for rabeximod.
   

Significant events after the end of the period

• Carl-Magnus Högerkorp is elected as a new board member until the next AGM.
• Cyxone receives patent approval from the US for the salt forms of the compound rabeximod.

CEO Carl-Magnus Högerkorp comments

We continue to gradually build our projects step by step. The focus is of course on the Phase 2b study APPRAIS with rabeximod in rheumatoid arthritis, but many other activities are continuously carried out to create a better foundation for both the rabeximod and T20K project.

Rabeximod advances with new approvals for the study APPRAIS

The preparations for the planned phase 2b study APPRAIS in patients with moderate to severe rheumatoid arthritis is progressing. In February, ethical and regulatory approval was obtained from the LEPL Regulation Agency for Medical and Pharmaceutical Activities in Georgia. Along with regulatory approvals from the Hungarian Medical Product Agency (National Institute of Pharmacy and Nutrition - OGYEI) and the Polish Medical Product Agency (Office for Registration of Medicinal Products, Medical devices and Biocides) and its Central Ethics Committee, the approval in Georgia is the third in a row and gives us a good starting point for the study. Together, these countries will contribute upwards of 65% of the patient base and are therefore very important.

In order to further document safety in the rabeximod project, we have conducted a follow-up non-clinical GLP study during the autumn and winter. In the dialogue we had with the American Medical Product Agency (Food and Drug Administration - FDA) during the summer of 2022, it was recommended to conduct this follow-up study. The study has been carried out during the winter and has also been complemented by a couple of further investigations to ensure the right quality level of the data that is generated. Currently, the final report of the study will be made available for the FDA's review, together with other non-clinical and clinical documentation.

Patent applications reach new milestones

Since patents are a very important component in the commercialization process of new drugs, the continuous work to develop and strengthen the company's patent portfolio is something that much time and resources are invested into. Cyxone works very strategically to further develop the company's patent protection. Since 2020, we therefore have several new patent applications in place for our various projects. During February, we were able to announce that four of our latest patent applications had reached the national phase. National phase means that the patent applications have come further in the process and are ready for examination at the national level in the regions and countries where it is advantageous to maintain patents from a marketing point of view, for example Europe, USA, China and several other parts of the world.

Important advances in the development of manufacturing processes

Other important aspects of the drug development process are manufacturing of the drug substance itself. During the early phases of development, small-scale manufacturing according to the principles of Good Manufacturing Practice (GMP) is important to establish. As the project advances, a more scalable process is necessary to get in place, that enables cost-effective manufacturing of the drug.

In the T20K project, we have worked with a process that makes it possible to produce substances based on chemical synthesis and enzymatic modification of the T20K molecule, a method based on work from the research group in Australia that has worked with T20K for many years. In March, the same research group reported new progress on a plant-based method to produce T20K. A plant-based process would eventually be a very interesting and cost-effective way to manufacture T20K.

In terms of continued optimization of a scalable manufacturing process for rabeximod, we made significant progress in Q1. One of the process steps could be significantly shortened by applying a different technology – from having previously required days, this step could be shortened to only requiring a few hours, which is very significant for a future scaled-up process.

New interest in immunology within the industry creates optimism

The Life Science sector is currently strongly affected by the current economic situation, where increased interest rates, unpredictability and inflation mean that the risk willingness on the market decreases. However, since Cyxone has mature projects that are far along in development, we have a good chance of generating interest from the industry. We see a renewed interest in immunology among the big companies. American Merck/MSD recently completed a major transaction through its purchase of Prometheus Biosciences, a company that develops drugs for a range of autoimmune conditions. This is a trend that is beginning to emerge, and therefore we have a very positive outlook on the future.

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

Carl-Magnus Högerkorp
CEO
Cyxone AB 

Upcoming financial reports and Annual General Meeting

2023

30 May                  Annual General Meeting

30 August            Half Year Report

27 October          Interim Report Q3

2024

23 February        Year-end Report 2023   

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 May 12, 2023
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, CEO
Tel: +46 (0)70 781 88 12
Email: carl.hogerkorp@cyxone.com

The information was submitted for publication, through the agency of the contact person set out above, on 12th of May 2023.

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