SynAct Pharma (SYNACT) Status Update summary

Recent developments and operating reset

• Phase IIb results in Sep–Oct 2023 missed the prespecified endpoints, prompting a strategic and organizational reset.

• A SEK 50 million directed issue was completed at a 30% premium; the investor base includes 16,000 shareholders.

• Management costs were cut 27% and board costs 46% in Q2 to extend the cash runway.

• A new CMO, Kirsten Harting, joined, and the board was refreshed with Anders Kronborg, Sten Scheibye and Sten Sørensen.

Resomelagon and rheumatoid arthritis strategy

• Resomelagon, formerly AP1189, is intended to reduce inflammation while promoting its resolution, without suppressing inflammation to levels that raise infection risk.

• Development will focus on early rheumatoid arthritis with active inflammation; in the identified subgroup, response was >80% on active treatment vs just over 50% on placebo.

• The subgroup had diagnosis within 6 months, high disease activity and signs of systemic inflammation; treatment was described as well tolerated.

• ADVANCE is planned as a Phase IIb study with 3 active doses vs placebo for 12 weeks; first patient is targeted for Q3 and results by end-2025.

• The Phase IIb program is fully funded; the aim is to prepare resomelagon for Phase III and potentially reduce early use of glucocorticoids and delay TNF blockers.

Pipeline and business development

• Business development with large pharma and biotech will continue, with a partner sought for the lead program after the planned data readout.

• Small-molecule programs are being prepared for clinical development; in the best-case scenario, a new compound could be ready to enter Phase I next year.

• RESOVIR collaborators are generating pharmacology data in virus-infection models to support protocols and applications for soft-money funding.

• A Capital Market Day is planned for September, alongside ongoing partner discussions and the ADVANCE study.