SynAct Pharma (SYNACT) investor relations material

Strategic focus and therapeutic approach

• Developing pro-resolution therapies to treat chronic and acute inflammation, aiming to delay or avoid use of biologic immune suppressors.

• Lead candidate resomelagon (AP1189) is a first-in-class oral treatment for rheumatoid arthritis (RA), targeting melanocortin receptors with a dual mechanism.

• Pipeline includes indications in RA, severe respiratory infections, dengue, polymyalgia rheumatica, and rare kidney diseases.

• SEK 100m financing in July 2026 supports Phase 3 readiness and ongoing clinical programs.

• Strong intellectual property protection extends exclusivity to 2044 in the US.

Clinical development and efficacy data

• Phase 2a BEGIN study showed significant reduction in disease activity and 60% ACR20 response in treatment-naïve RA patients.

• Phase 2b EXPAND and ADVANCE studies demonstrated safety and efficacy in subgroups with high inflammation, with ACR20 rates on par with JAK/TNF inhibitors.

• Post-hoc analyses identified optimal patient populations and dosing, informing Phase 3 design.

• Safety profile supports first-line use, with no signs of immunosuppression and mostly mild/moderate adverse events.

Market opportunity and positioning

• Addressable US RA market includes 800,000 moderate-to-severe patients with high CRP, with 90,000 new cases annually.

• No approved pre-biologic add-on therapy exists, creating a significant market white space.

• Payer research supports early use of resomelagon at a discount to biosimilar TNF inhibitors.

• Active partnering discussions for RA and infectious disease indications.