SynAct Pharma (SYNACT) investor relations material

Strategic focus and development programs

• Advancing a dual development strategy for resomelagon (AP1189) in rheumatoid arthritis and severe viral infections.

• Main project targets newly diagnosed rheumatoid arthritis patients with high disease activity and poor prognosis factors.

• Host-directed therapy program addresses hyper-inflammatory responses in severe viral infections, leveraging lessons from the COVID pandemic.

• Emphasizing a first-in-class, non-suppressive therapy that modulates immune response without increasing infection risk.

• Pipeline includes a phase 2B rheumatoid arthritis study and ongoing collaborations for viral infection studies.

Clinical progress and milestones

• Over 80% of patients recruited for the 240-patient phase 2B rheumatoid arthritis study, with key results expected next year.

• Previous studies showed higher response rates in newly diagnosed patients compared to placebo, supporting ongoing trials.

• Additional clinical studies in viral infections are underway, including collaborations in Denver and Brazil.

• Major milestone is the upcoming data readout in the first half of next year, with further updates planned as recruitment completes.

• Respiratory insufficiency studies in Brazil are ready to launch, pending seasonal factors.

Scientific approach and differentiation

• Therapy aims to modulate immune response by shifting macrophage phenotype to promote resolution of inflammation.

• Focus on stimulating melanocortin receptors to enhance efferocytosis and clear inflammation.

• Approach seeks to reduce reliance on glucocorticoids and postpone second-line treatments in early rheumatoid arthritis.

• Oral, once-daily, well-tolerated treatment positions the therapy as patient-friendly and first-in-class.

• Growing industry understanding and interest in resolution therapy, with few direct competitors advancing similar oral compounds.