During 2023 a range of new biosimilar disease modifying anti-rheumatic drugs (DMARDs), approved by the US Food and Drug Administration, FDA, have been broadly introduced to the American market. As a result, patients with moderate to severe rheumatoid arthritis that have inadequate response to methotrexate will now be offered a range of less costly TNFa inhibitor alternatives. However, the segment of patients - up to 50% - that do not adequately control disease with this class of drugs, lack alternatives. Rabeximod, an oral synthetic DMARD in phase 2, exploiting a novel mechanism of action, and with demonstrated effect in patients with moderate to severe rheumatoid arthritis is a leading contender for targeting inadequate response to DMARDs, such as TNFa inhibitors.

Due to this, Cyxone has decided to shift its development strategy to focus on a growing market segment with underserved patients not sufficiently helped by current therapeutic options. Going forward, rabeximod will be explored in a fast-tracked development program consisting of small exploratory studies, investigating the compound in patients with inadequate response to the TNFa inhibitor class of medicines.

Besides this change of priority, the development program and activities now planned will lead to lower costs in 2024-2025 than previously anticipated, and acquired know-how and material assets from previous study activities will instead be transferred to the new development activities and form the basis of a series of new smaller "proof-of-concept" studies. Importantly, the strategy change is centered around the recent development progress for the new unique formulation of rabeximod, for which a valuable US patent was granted in May of 2023, providing an additional 20 years of patent lifetime.

"We are confident that this strategy change is well aligned with current needs in the treatment landscape, as many patients that do not experience sufficient disease control on these drugs have few alternatives today. During the past couple of months, the Cyxone medical team have worked diligently, conducting a range of interviews with key opinion leaders in the USA and Europe. Based on these interviews we have now established a clear understanding of how to best position rabeximod in a future treatment regime, to meet the needs of many underserved patients and at the same time maximize shareholder value. We are very excited about this directional change, fully supported by the highly experienced new board of directors, and the exciting opportunities ahead", says Carl-Magnus Högerkorp, CEO at Cyxone.

Contact

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

This information is information that Cyxone AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 29 August 2023.

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. For more information, please visit www.cyxone.com