February 18, 2026
Advancing toward the most important data readout in SynAct’s history
As we close the first quarter of 2026, SynAct Pharma is in a stronger position than at any previous point in the company’s history: clinically, operationally and financially. The defining moment of this year is close. Following the end of the quarter, on May 6, we announced that the last patient had completed dosing in our Phase 2b ADVANCE study. Topline data are expected in June, and significant momentum is built toward this readout.
The ADVANCE study is a prospective, double-blind, placebo-controlled study in 246 newly diagnosed RA patients with high disease activity and active systemic inflammation, the target population where resomelagon has consistently shown its strongest signal. The study tests three doses of resomelagon in combination with Methotrexate, with DAS-28-CRP reduction at week 12 as the primary endpoint. It is designed to identify doses for Phase 3 and to give us and potential partners a clear and definitive read on resomelagon’s efficacy and safety profile in this setting. We have prepared carefully. We are ready.
Interest from potential strategic partners is real, and it is growing as we approach the data. Resomelagon’s differentiated profile, a non-suppressive mechanism that works with the immune system rather than against it, is increasingly well understood in the pharmaceutical industry. Positive ADVANCE data is the key event that will move partnering conversations forward. We are well prepared.
The quarter itself was active on multiple fronts. In March, we hosted our Capital Markets Day in Stockholm, where we provided a comprehensive update on resomelagon’s clinical strategy in RA and our host-directed therapy program in viral infections. The event strengthened our dialogue with key investors and analysts at a critical juncture. During the first quarter, we increased our partnering outreach at the J.P. Morgan Healthcare Conference, Bio-China, and BIOEurope Spring. In the second quarter, we are further building momentum at regional and global meetings culminating at the BIO International in San Diego in June being one of biggest partnering events of the year.
On the pipeline we are currently recruiting patients to the RESOVIR-2 study in Dengue fever in Brazil. We have since the first recruitment in late March had a steady increase in number of inclusions and will continue in June as Mosquito season at site seems to continue. To secure progress in the RESPIRE study site on the southern hemisphere has been identified with the aim benefit of the upcoming season. These programs are not merely optionality. They reflect a growing body of clinical evidence supporting resomelagon as a platform asset across multiple inflammatory settings.
Financially, we completed a directed share issue of approximately SEK 51.9 million in early March, strengthening our balance sheet and extending our cash runway. This secures the company through the ADVANCE data readout and into the period that follows it, including the business development process that positive results would unlock. Shareholders should note this financing as a deliberate positioning ahead of a value inflection point, not a reactive move.
On the leadership side, we welcomed Ann Kristin Led as our permanent Chief Financial Officer in February. With our team now complete and our clinical program finalizing proof-ofconcept in RA, we are well placed to manage what comes next, including, if results warrant, the rapid transition into Phase 3 readiness and commercial partnering discussions.
Jeppe Øvlesen | CEO