SynAct Pharma (SYNACT) Company Presentation summary

Company overview and recent milestones

• Listed in 2016, SynAct Pharma focuses on resolution therapy for inflammation, with lead asset Resomelagon (AP1189) advancing through clinical development in autoimmune and viral diseases.

• Achieved proof of concept for Resomelagon in both COVID-19 and rheumatoid arthritis (RA) Phase 2 studies; ongoing Phase 2b ADVANCE study in RA and RESOVIR-2 study in dengue.

• Acquired TXP Pharma in 2023, expanding the preclinical pipeline for organ protection and acute care indications.

• Completed two financing rounds in 2024 totaling €11M, supporting a focused, cost-effective strategy and management changes.

• Strengthened management and board, reduced costs, and prioritized key indications for development and partnership opportunities.

Lead asset: Resomelagon (AP1189)

• Resomelagon is a once-daily oral therapy designed to induce pharmacological resolution of inflammation, restoring immune homeostasis.

• Demonstrated significant reduction in disease activity and improved quality of life in newly diagnosed RA patients, with a favorable safety profile and no immunosuppression.

• Fits into current RA treatment guidelines as a first-line add-on to methotrexate, with potential to reduce glucocorticoid and biologic use.

• Early intervention in RA is critical, as joint damage occurs within the first 2-3 years; Resomelagon targets high disease activity patients.

• Attractive business case with a large and growing RA market (>900,000 new cases/year, >$20B market, >5% CAGR).

Clinical development and pipeline

• ADVANCE Phase 2b study in RA is ongoing in the US and Europe, targeting newly diagnosed, treatment-naive patients with high disease activity; primary endpoint is change in DAS28-CRP over 12 weeks.

• RESOVIR-2 Phase 2 proof-of-concept study in dengue fever initiated in Brazil, with recruitment planned for the next epidemic; primary endpoint is reduction in composite disease score.

• Additional indications in development include idiopathic membranous nephropathy (rare disease), organ protection (TXP-11, preclinical), and other autoimmune/inflammatory diseases.

• Positive Phase 2 data in severe COVID-19 showed faster recovery and shorter hospitalization, supporting host-directed therapy in viral infections.

• Pipeline includes discovery-phase next-generation compounds and plans for Phase 1 initiation of TXP-11 in 2026.