OCTOBER 30, 2024

The SynAct team continued to work focused during the third quarter as the company initiated the Phase 2b ADVANCE study in patients with newly diagnosed severe rheumatoid arthritis (RA) with the company’s lead compound resomelagon (AP1189). There are more than 400,000 newly diagnosed patients each year in the Western World of which a large fraction would benefit from treatment with resomelagon as a new effective and safe treatment option.

Many patients will not reach the treatment goal of disease control in a timely manner with the current treatment options. Even though a large fraction of patients is cotreated with glucocorticoids and/or introduced to expensive biologics at an early stage in the treatment. Compounds who have unwanted side effects, meaning that their use should be reduced or postponed as much as possible. Together this setting has created an opportunity for resomelagon to be a novel patients friendly
treatment option, lowering the need for glucocorticoids and postponing the use of biologics to later stages. There is a clear market need for resomelagon, and we have an ambitious plan to support these patients.

This year SynAct refocused itself by raising new funding at a premium, reducing its cost structure and laying out a new plan to push resomelagon forward. The company has a strong management team and board in place and is excited to see ADVANCE, which is a double-blind, placebo-controlled, Phase 2b clinical multi-center study conducted under the company’s USIND in RA. Active recruitment has already been initiated at sites in the US. Approval has been given in the first non EU country in Europe and it is expected to have approval in EU in Q4. We plan to have recruitment across more than 20 sites in a total of seven countries before the end of this year. The study is on track with enrollment of all patients planned to be completed in Q4 2025 and key results expected as soon as possible thereafter.

During the third quarter we hosted a Capital Markets Day in Stockholm to share our latest views on the science and development, the market potential and listen to experts talk about the patient need for a better solution in RA. We heard from the management team and board about our strategy forward, the science behind resomelagon, as well as from the CSO at Sanos Group about the medical need for an early-line treatment. It was a great opportunity for us to connect with our shareholders and those interested in SynAct, so many thanks to all of those who participated.

SynAct is in a strong position now to execute on the ADVANCE study. I want to thank the team for all of their hard work, as well as those shareholders who believe in us and the potential for resomelagon to change the lives of RA patients.

Jeppe Øvlesen | CEO and Board Member