Board Change • 5h
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 2 experienced directors. No highly experienced directors. Member of Clinical Advisory Board Roy Fleischmann is the most experienced director on the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. 공시 • Jun 17
SynAct Pharma AB Reports Positive Results from Phase 2B Advance Study of Resomelagon in Rheumatoid Arthritis SynAct Pharma AB reported that resomelagon in combination with methotrexate showed promising clinical effects on par with previous findings with ACR20 reaching 76.4% in the most effective dose compared to 60.8% in the placebo treated control group (p=0.06, per protocol data set) reaching statistical significance in the subset of patients entering the study with ACR/EULAR class II-III disease, (76.9% vs. 56.5%, p=0.03). The treatment potential was further supported by a significant reduction of CRP (p=0.0037) which was not present in the placebo treated control group. In addition, resomelagon induced a larger reduction in the Simplified Disease Activity Index (SDAI) (p=0.03 vs placebo). Overall, the safety profile of the compound was very good, and the compound was well tolerated. No signs of immune suppression were observed. The ADVANCE (SynAct-CS008) study was a multicenter, randomized, double-blind, placebo-controlled, 12-week study in newly diagnosed, treatment naïve patients with highly active Rheumatoid Arthritis (RA) (Clinical Disease Activity Index (CDAI) > 22; DAS28-CRP >5.1 and hsCRP > 3 mg/L) conducted at sites in Europe and USA. 246 patients were randomized with the aim of confirming the potential of the compound as a novel safe treatment option in RA and identify feasible doses for further (phase 3) clinical development. The study identified 40 mg given once daily as the most effective dose showing reduction in all clinical parameters on par with what has been seen in previous studies. The study confirmed the hypothesis of non-linear dose-response for resomelagon. Per protocol, 42 out of 55 (76.4%) (p=0.06) treated with 40 mg resomelagon reached ACR20 response compared to 31 out of 51 (60.8%) of those treated with Placebo. ACR50 response was reached in 21 of the 55 (38.9%) vs 18 out of 51 (35.3%) in the placebo group. Deeper clinical response like ACR50 continues to improve after ACR20 saturation, indicating that the ACR50 response will continue to increase with treatment beyond 12 weeks of treatment with resomelagon. In patients entering the study with disease classification ACR/EULAR class II and III further substantiated the potential of resomelagon as ACR20 response reached statistical significance in these patients with 40 out of 52 (76.9%) in the 40 mg resomelagon group versus 26 out 46 (56.5%), (p=0.03) in the placebo treated group. Resomelagon in all dose-groups induced a statistically significant reductions in CRP. The resomelagon 40 mg group, CRP (mean values) went from 23.0 to 9.5 mg/L (p=0.0037), compared to 17.7 to 12.0 mg/L (not significant) in the placebo treated group. The mean reduction in the clinical relevant Simplified Disease Activity Index (SDAI) was 35.9 in the resomelagon 40 mg group versus 28.5 (p=0.03) in the placebo group. As per FDA guidance, DAS28-CRP and SDAI are interchangeable measures to be used for dose response studies. Whereas the response to resomelagon was on par with what has been reported previously (BEGIN and subgroup analysis in EXPAND) the least square mean of reduction in DAS28-CRP (primary endpoint) in the per protocol subjects was 1.98 (SE 0.14) vs 1.79 (SE 0.14) in the placebo treated group (p=0.168). The reduction in the placebo treated group was around 50% larger than what was seen in previous studies which made the primary endpoint inadequate to reach significance within the limits of the study design. Overall, the safety profile of the compound was very good and the compound was well tolerated, no signs of immune suppression were observed, no serious adverse event was reported in the resomelagon treated groups, and reduction in the background treatment with methotrexate due to lack of tolerance was only reported in the placebo treated control group. The results from the ADVANCE study are expected to further fuel partnering and licensing discussions. The ADVANCE study was a 12-week randomized, double-blind, multicenter, placebo-controlled Phase 2b study with repeated doses of 40mg, 70mg, and 100mg of AP1189 and placebo. The study includes 246 newly diagnosed patients with Rheumatoid Arthritis (RA), with elevated inflammation levels (CRP levels above 3mg/l), severe disease symptoms, and ready to initiate 1st line methotrexate therapy. Resomelagon in addition to 1st line methotrexate therapy may be a safe and effective way to reduce disease symptoms and may prolong or prevent the need for additional therapy typically adding glucocorticoids and biologic DMARDS. 공시 • Feb 18
SynAct Pharma AB (OM:SYNACT) commences an Equity Buyback Plan for SEK 10 million, under the authorization approved on November 27, 2025. SynAct Pharma AB (OM:SYNACT) commences share repurchases on January 12, 2026 under the program mandated by the shareholders in the Extra ordinary General Meeting held on November 27, 2025. As per the mandate, the company is authorized to repurchase for SEK 10 million worth of its share, such that the company’s holding in treasury together with the shares repurchased does not exceed 10% of its issued share capital at any point of time. The shares will be repurchased at a price which falls within the prevailing price interval registered at each point in time (i.e. in the interval between the highest purchase price and the lowest selling price). The purpose of the program is to adapt the company’s capital structure and thereby contribute to increased shareholder value. The repurchased shares will be cancelled by resolution of upcoming Annual General Meetings. The program is valid until the next Annual General Meeting in 2026. As of October 29, 2025, the company had 53,330,243 shares outstanding and no shares in treasury.
On January 9, 2026, the company announced a share repurchase program. Under the program, the company will repurchase up to SEK 5 million. The repurchase shall be made in cash. The repurchases will commence from January 12, 2026, and will be valid till February 28, 2026. 공시 • Feb 07
SynAct Pharma AB (publ) Successfully Reaches Recruitment Goal in Ph2b Advance Study SynAct Pharma AB (publ) has successfully reached the recruitment goal of 240 randomized subjects in the 12-week Ph2b ADVANCE study of resomelagon in newly diagnosed patients with Rheumatoid Arthritis (RA). After the last patient passes 12 weeks, follow-up visit, and completes the study, the process of closing the database across more than 30 sites will commence ensuring all data is included per protocol. Following this, statistical analysis and evaluation of the results will be done before top-line results are shared. 공시 • Jan 19
SynAct Pharma AB Appoints Malin Wikstrand as Interim Chief Financial Officer, Effective January 19, 2026 SynAct Pharma AB announced that Malin Wikstrand has been appointed interim Chief Financial Officer (CFO), effective as of January 19, 2026. Malin Wikstrand has been with SynAct Pharma since 2016 and currently serves as Financial Controller. In her current role, she has been closely involved in the development and daily operation of the company’s finance function and has strong knowledge of SynAct’s financial structure and reporting processes. Malin has broad experience from central finance roles within listed environments. The appointment coincides with Björn Westberg stepping down from his position as CFO, as previously communicated. 
