October 30, 2025
Expanding the opportunity for resomelagon
SynAct maintains the momentum from the past quarters and is advancing key clinical trial for resomelagon; raised SEK 35.4m to support development of current projects and stretched runway to 2027; and strengthened the leadership team with Mads Bjerregaard as new Chief Business Officer.
With two parallel development tracks, we continue to expand our understanding of potential clinical uses for resomelagon (AP1189), a potential first-in-class non-suppressive therapy for inflammatory diseases. The first being early intervention in autoimmune diseases with primary focus on rheumatoid arthritis (RA) and the second on host-directed treatment in viral infections, a segment in which we see substantial potential. We are excited about the potential application of resomelagon for millions of patients as a safe and effective treatment alone or together with standard of care therapies.
In autoimmune diseases, the Phase 2b ADVANCE study in patients with newly diagnosed severe rheumatoid arthritis (RA) remains on track to enroll the 240 patients in Europe and the US before the end of 2025. This study will confirm the treatment potential of resomelagon to identify optimal doses for Phase 3 development in patients with newly diagnosed RA. These results will be critical for understanding resomelagon’s potential across different stages of the disease and for initiating Phase III and commercialization discussions.
Earlier this year we announced the company would initiate an explorative Phase 2 study in patients with Polymyalgia Rheumatica (PMR). This study will be initiated in H2 2025 at sites in Denmark. The goal is to explore the potential of using resomelagon and discontinue the use of glucocorticoids in PMR.
In acute inflammation applications, SynAct is developing resomelagon for host-directed viral inflammation where a previous Phase 2a study in hospitalized COVID-19 patients in Brazil demonstrated faster recovery, lower ICU admission rates, and shorter hospital stays. Building on this, we started a Dengue virus study in Brazil, where we expect to begin recruiting early next year during the Dengue season. Hostdirected viral inflammation could become a significant future opportunity for resomelagon and another catalyst for partnership discussions, so the team is working hard to map out our path forward on this development track.
Extended runway
We are extremely fortunate to have investors who understand and value our strategy. Adding to the 37 million kronor we raised from several existing shareholders earlier this year and gaining a credit line for SEK 30 million, SynAct also raised 35.4 million with Heights Capital Management converting warrants on two separate occasions during the third quarter. To show commitment, all members of the board and executive management agreed to a lock-up arrangement for their shares in the company until the end of 2025. We now have a cash runway into 2027 with the studies planned.
To accelerate our plans and help ensure we execute on our commercial and partnering opportunities, Mads Bjerregaard joined as Chief Business Officer at the start of September. Jim Knight, who was CBO since 2021, will join SynAct’s advisory board and continue supporting the company. Mads sits with our management team in Denmark and has already proven himself invaluable in outreach and market access planning.
SynAct is in a fortunate position now as the company has two development tracks, across both autoimmune and infectiondriven inflammation, for resomelagon. Both of which are amazing opportunities to support patients and will be key in upcoming business development activities. Looking further ahead, resomelagon’s unique ability gives us the option to expand into additional inflammatory or autoimmune indications where restoring immune balance is key.
I couldn’t be happier with what we’ve accomplished so far this year. We are coming closer to wrapping up the Phase 2b ADVANCE study and we are working hard to make sure we have the right strategy to maximize resomelagon’s potential within infection-driven inflammation. We are incredibly grateful for all the support we get. It gives us energy to push forward.
Thanks for following SynAct.
Jeppe Øvlesen | CEO