August 20, 2024

The second quarter of 2024 was a period of remarkable progress and strategic execution for SynAct Pharma. Building on the momentum from Q1, our dedicated team is focused on propelling resomelagon back into clinical trials within RA (Rheumatoid Arthritis) after strengthening our financial and operational foundations. We are confident resomelagon has incredible potential for early intervention in patients with severe RA, so progressing with ADVANCE is top priority.

Our focus is on taking resomelagon back into the clinic with the Phase IIb randomized, double-blind placebo controlled clinical multi-center study with the company’s lead compound resomelagon (AP1189) at sites in the US and in Europe.

These RA patients are often cotreated with glucocorticoids (GCs) while second line treatment with biologics, such as the TNF-blockers, will frequently be introduced early on to boost the likelihood of controlling the disease. Unfortunately, these treatment options are associated with unwanted side effects. Resomelagon has the potential to be a novel treatment option, reducing the need for GCs and potentially postponing the use of the biologics to later stages of the disease.

We already submitted the clinical trial protocol for ADVANCE in the US to be done under the existing FDA-IND for development within RA. We have also turned in a clinical trial application with the European Medicines Agency covering 5 countries across the EU, including Denmark, as well as one additional non EU European country.

The team has a clear and ambitious plan for driving ADVANCE forward and we are on track to start recruitment during Q3 2024 and complete enrollment during Q4 2025 . We are excited by the progress being made and will update the market as we progress. Resemelagon clearly has potential in RA, but we believe there is much more to do going forward. ”We are confident resomelagon has incredible potential for early intervention in patients with severe RA, so progressing with ADVANCE is top priority.”

Thanks to the SEK 49 million we raised at a premium at the end of Q1 2024 and the reduced cost structure, SynAct has a solid f inancial position to continue developing resomelagon with the ADVANCE clinical trial. We now have a stronger base of investors and the supportive Board of Directors and management team ready to help ensure SynAct reaches its potential.

I want to thank all the shareholders for following SynAct. We have an incredible future ahead of us.

Jeppe Øvlesen | CEO and Board Member