Interim Report Q3 2022 – November 4, 2022

Building a strong business case around AP1189

The hard work during the first half of the year continued during the third quarter. After a long period preparing, the company f inally made the leap to the main list at Nasdaq Stockholm, while at the same time we pushed our pipeline forward. Shareholders have placed a great deal of trust in SynAct, and we remain determined to execute on our ambitious plan for AP1189.

Making the move to Nasdaq Stockholm was a big moment for the company and truly is a stamp of quality for the organization we have built over the years. Being traded on the main list gives us greater access to even more international and institutional investors, critical for executing on our growth plan.

Following the Clinical Trial Application approval for the Phase 2b EXPAND study in rheumatoid arthritis (RA) using our candidate drug AP1189, we moved quickly to enroll our first patient. This first patient in Moldova is a nice milestone for the EXPAND study, and we will continue to enroll additional patients there and in Bulgaria.

AP1189 targets an unmet need for a novel treatment option in RA. Our compound aims to stimulate an immunological resolution, a unique treatment approach that we expect to have a significant impact on how the medical system tackles RA but also other autoimmune and inflammatory diseases.

The EXPAND study follows the successful results from the BEGIN study that showed AP1189 to be safe, well tolerated and induce a statistically significant reduction in disease. To bolster the position of AP1189 as a novel compound with a unique mode of action in resolution of inflammation, several exploratory endpoints are included in EXPAND, such as MRI-scanning of affected joints.

Topline data is expected to be ready during the second half of 2023, assuming recruitment goes smoothly. EXPAND results will be pivotal in the ongoing interactions with potential partners and for the further development of AP1189.

The team pushed hard to file the investigational new drug (IND) application with the US Food and Drug Administration for the planned Phase 2a/b study called RESOLVE before the end of the third quarter. Following a very straightforward process with the agency, we obtained the IND without any comments to the proposed and previously communicated clinical study design. We are looking forward to initiating the study and collaborate with investigators and key opinion leaders in the US.

Advancing the development program in rheumatoid arthritis is our main focus, but we still believe AP1189 has a role as a safe and effective treatment of kidney diseases related to proteinuria and nephrotic syndrome (NS). Before the summer, we re-assessed and re-designed our clinical Phase 2a study in idiopathic membranous nephropathy (IMN) patients, (SynAct-CS003). Through the new design recruitment to the study should be accelerated, and we hope to obtain proof-of-concept in a third disease for AP1189 during 2023.

As mentioned, SynAct’s efforts with AP1189 in RA is the main focus. We continue to have business development discussions, and our hard work hasn’t gone unnoticed. Our goal is to build a rocksolid case around the mode of action for AP1189, going beyond producing clinical results. This is why we are including tertiary endpoints to further explore the effect of AP1189 on biomarkers and by evaluation of synovial inflammation using magnetic resonance imaging (MRI). Our aim is to identify the full treatment potential of the compound.

In the third quarter, our operating expenses were SEK 26.5 million, an increase of 27% over the same period last year. R&D investments were SEK 20.6 million or 27% higher than Q3 2021. General and Administration costs fell as predicted to SEK 5.7 million in the quarter, from SEK 12.1 million in the previous quarter and up 23% from the same period last year

It is exciting to see the company’s pipeline continue to advance and the business case around AP1189 strengthening. SynAct has a strong pipeline and the programs are on schedule. We remain busy exploring business development opportunities. Thank you for showing interest in the company.

Jeppe Øvlesen, CEO