SynAct Pharma (SYNACT) Company presentation summary

Scientific and clinical approach

• Focuses on pro-resolution immunology, targeting chronic and acute inflammatory conditions through macrophage modulation via melanocortin receptors (MC1r/MC3r).

• Resomelagon (AP1189) is a potential first-in-class, non-immunosuppressive, once-daily oral therapy with Phase 2b data supporting further development in rheumatoid arthritis (RA) and broader inflammatory diseases.

• Mechanism of action involves biased agonism of MC1r and MC3r, reducing pro-inflammatory cytokines and promoting tissue healing without immune suppression.

• Organ-independent pharmacology supports development across multiple indications, including RA, viral infections, osteoarthritis, gout, and autoimmune diseases.

Clinical development and results

• ADVANCE Phase 2b study in newly diagnosed, treatment-naïve RA patients showed resomelagon plus MTX improved ACR20/50/70 responses and inflammation markers compared to placebo.

• Safety profile is benign, with no signs of immunosuppression and most adverse events attributed to MTX rather than resomelagon.

• Efficacy on par with leading biologics and JAK inhibitors, with potential for deeper response over extended treatment.

• Ongoing and planned studies include Phase 2 trials in viral respiratory infections (RESPIRE), dengue (RESOVIR-2), and other inflammatory conditions.

Market opportunity and strategy

• Addressable US market for pre-biologic, MTX add-on therapy in RA estimated at 600-800k patients, with a total diagnosed population of 1.6-1.7 million.

• Global RA market valued at $26 billion, with 18 million patients worldwide and significant unmet need due to inadequate response to first-line therapies.

• No approved pre-biologic add-on therapies currently exist, positioning resomelagon to define a new treatment category.

• Platform technology and patent protection extend exclusivity for resomelagon until at least 2044 in the US.