SynAct Pharma (SYNACT) CMD 2024 summary

Strategic Focus and Business Development

• Strategy centers on advancing the ADVANCE Phase 2b study in newly diagnosed, high-activity RA patients, aiming for data by end of 2025 and subsequent business development or partnership opportunities.

• Raised SEK 50 million at a premium, securing a cash position of around SEK 60 million, and implemented cost reductions to fund operations through the next major data readout.

• Actively engaging with Big Pharma, specialty, and regional partners, maintaining ongoing dialogue to align development with market needs and maximize deal potential.

• Exploring non-dilutive funding sources such as grants to supplement financing and enable parallel development in additional indications if resources allow.

• Open to various deal structures, including regional licensing or full acquisition, to optimize value and accelerate global market entry.

Clinical Development and Scientific Positioning

• ADVANCE study targets newly diagnosed RA patients with high disease activity and elevated CRP, using DAS28-CRP as the primary endpoint and enrolling across 7 countries.

• Four patient cohorts receive placebo or one of three resomelagon doses (40, 70, 100 mg) daily for 12 weeks, in combination with methotrexate.

• Previous studies (BEGIN, EXPAND) showed strong efficacy and safety, with up to 82% ACR20 response in newly diagnosed, high-inflammation patients and tolerability comparable to JAK inhibitors.

• Resomelagon acts as a biased agonist of the melanocortin system, promoting resolution of inflammation without immunosuppression, differentiating it from current anti-inflammatory and immunosuppressive therapies.

• Pipeline includes potential expansion into viral hyperinflammation, nephrology, and other indications, with further development contingent on funding and strategic focus.

Market Opportunity and Competitive Landscape

• RA market is large and underserved, with over 400,000 new diagnoses annually in the US and Europe, and a global market potential estimated at $30 billion by 2030.

• Resomelagon + MTX could address a >$2B annual market for early, high-activity RA patients.

• Current RA treatments leave a significant efficacy gap, with 20–40% of patients not responding to aggressive first-line therapies and all major options carrying serious safety risks.

• Most pipeline drugs remain immunosuppressive, highlighting the need for new, immune-preserving, and convenient oral therapies like resomelagon.

• Additional indications such as IBD, dry eye, and viral-induced hyperinflammation are of interest to potential partners, supporting a pipeline-in-a-pill strategy.