February 18, 2026
Expanding the opportunity for resomelagon
As we close the fourth quarter and conclude 2025, I am pleased with the steady progress SynAct Pharma has made across clinical execution, corporate development and external validation. Our focus remains firmly on advancing resomelagon (AP1189), our potential first-in-class nonsuppressive therapy for inflammatory diseases, toward meaningful clinical and strategic value creation.
During the quarter, we continued to advance our Phase 2b ADVANCE study in rheumatoid arthritis (RA). In early February we finalized the recruitment with 246 patients reinforcing momentum toward topline results, that I know we are all eager to see. This operational achievement underscores our team’s executional strength and strong collaboration with our clinical research organization NBCD. After the last patient visit following 12 weeks treatment period and follow up, data will be collected and analyzed.
We continue to see strong interest from potential business partners in resomelagon. The ADVANCE data will provide a clear direction for business development discussions on how best to position resomelagon as a strategic asset for future growth in an immune and inflammation disorders business. Our dual development strategy is coming to fruition and delivering expanded opportunities.
In parallel with our RA study, we have actively pursued expansion of our opportunity for host directed therapy for acute inflammation due to viral infections. In February we announced the approval of the European Phase 2 RESPIRE trial in patients admitted to hospital for respiratory insufficiency due to respiratory viral infections such as influenza, Covid-19, and RSV. An application of resomelagon in respiratory insufficiency is an opportunity to address a large hospital market of about 2 million people in the U.S. and Europe that need hospital care due to respiratory viral infections.
In parallel, we are ready to start enrollment in the Dengue trial in Brazil once the dengue season arrives in Q1. We are also hosting a Capital Markets Day on March 11th in Stockholm, where we will focus on our latest update on our position in rheumatoid arthritis and on our application in respiratory viral infections.
During the quarter Björn Westberg announced he was stepping down from his role. In January we agreed with Malin Wikstrand, who has served as Financial Controller since 2016, to take on interim CFO responsibilities. A heartful thanks to Malin for stepping up and to Björn for his commitment to the company.
In November we announced a share buy-back program of SEK 10m. An initial SEK 5m was acquired in the market during January and February. Execution of the remaining part of the program will be decided in the months to come and as of today we have not use the credit facility.
The fourth quarter was marked by active engagement with investors, partners and the broader life sciences community. SynAct representatives presented and participated at multiple industry events, including BioEurope in Vienna, Austria, which is one of the biggest platforms of the year to reach potential partners, BioStock Life Science Summit 2025 and at Redeye’s Autoimmune & Inflammatory Diseases event — platforms that allowed us to share our scientific rationale, clinical strategy and long-term vision.
Most recently, our team attended the J.P. Morgan Healthcare Conference in San Francisco, where we engaged with global investors and strategic stakeholders and further educated the market on the opportunities ahead for resomelagon. These engagements are an important part of building understanding and visibility as we progress toward key catalysts.
In the coming months, SynAct will be engaged at partnering meetings in Europe, China, Middle East, and the Bio International in the U.S. to ensure maximum attention on upcoming data readouts. We also saw coverage initiated by Edison Investment Research, a step that amplifies market recognition of our differentiated approach and provides broader analytical visibility into our clinical and strategic trajectory.
Looking ahead, 2026 is shaping up to be a particularly busy and transformative year for SynAct. With key clinical data expected from the ADVANCE study, continued strategic dialogue with potential partners, and an expanded leadership team in place, we enter the year with clear priorities and strong momentum. Our focus remains on delivering highquality data, advancing our pipeline, and creating long-term value for patients and shareholders.
I would like to thank our employees, investigators, partners and shareholders for their continued commitment and support as we move into this important next phase for SynAct.
Jeppe Øvlesen | CEO