New Risk • Aug 21
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr112m Forecast net loss in 2 years: kr7.2m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr101m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (kr7.2m net loss in 2 years). Breakeven Date Change • Aug 21
Forecast breakeven date pushed back to 2028 The 2 analysts covering SynAct Pharma previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 38% per year to 2027. The company is expected to make a profit of kr28.5m in 2028. Average annual earnings growth of 109% is required to achieve expected profit on schedule. Tillkännagivande • Jul 10
SynAct Pharma Reports Early Preclinical Results Showing Resomelagon Attenuates Osteoarthritis Associated Inflammation And Joint Damage SynAct Pharma AB announced that early preclinical results show resomelagon (AP1189) attenuates osteoarthritis associated inflammation and joint damage, thereby reducing pain through activation of pro-resolving signaling pathways. Data was presented at a scientific session with Resovir collaboration partner Universidade Federal de Minas Gerais in Brazil. Osteoarthritis (OA) is a highly prevalent joint disorder affecting 595 million people globally characterized by chronic pain and functional impairment. Increasing evidence indicates that sustained low-grade inflammation contributes to disease progression and structural joint damage. The group led by Flávio Almeida Amaral, Department of Biochemistry and Immunology, Institute of Biological Sciences, Federal University of Minas Gerais, set up an experimental model of induced osteoarthritis in mice (destabilization of the medial meniscus, DMM) and evaluated effects on joint damage, pain, and inflammation. Preliminary findings indicate that resomelagon modulates early inflammatory responses following DMM surgery. Treatment was associated with altered mononuclear cell dynamics, regulation of melanocortin receptor expression, and reduced histopathological joint damage, suggesting an impact on disease progression. Further data to be presented at the WCI2026 (17 World Congress of Inflammation) to be held in Foz do Iguaçu, Brazil, September 8-12, 2026. Reference: 1) Lancet Rheumatol 2023; 5: e508–22. Tillkännagivande • 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. New Risk • Jun 09
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 8.9% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr101m free cash flow). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (8.9% average weekly change). Market cap is less than US$100m (€69.9m market cap, or US$80.7m). New Risk • May 28
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr101m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr101m free cash flow). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (€82.7m market cap, or US$96.1m). Board Change • May 20
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. Tillkännagivande • 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. Tillkännagivande • 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. Tillkännagivande • 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. Tillkännagivande • Dec 12
SynAct Pharma AB, Annual General Meeting, Jun 11, 2026 SynAct Pharma AB, Annual General Meeting, Jun 11, 2026. Tillkännagivande • Sep 16
Björn Westberg to Leave SynAct Pharma AB as CFO SynAct Pharma AB (publ) announced that the company’s CFO Björn Westberg is leaving the company when a successor has been appointed. Current CFO Björn Westberg has decided to pursue another opportunity and will leave the company later this year when his successor is appointed. Tillkännagivande • May 27
SynAct Pharma AB Elects Jeppe Ragnar Andersen as Members of the Board of Directors SynAct Pharma AB at its annual general meeting held on May 27, 2025, elected Jeppe Ragnar Andersen as members of the Board of Directors for the period until the next annual general meeting. Tillkännagivande • May 12
SynAct Receives Issue Notification and Patent Term Adjustment for US Patent Covering Resomelagon (Ap1189) Combination Therapy SynAct Pharma AB (publ) announced that the Unites States Patent and Trademark Office (USPTO) has provided the issue notification of US patent 12,303,489 with issue date 20 May 2025 and more than 2 years of Patent Term Adjustment added to the patent's expiry date. SynAct's recently announced that US patent application 17/609,849 with claims covering a method of treating rheumatoid arthritis (RA) with resomelagon (AP1189) in combination with methotrexate (MTX) had been allowed for grant of a US patent. The USPTO has now provided the Issue Notification with an issue date for US patent 12,303,48 of 20 May 2025. Importantly, the Issue Notification also determines that the US patent is awarded a Patent Term Adjustment (PTA) of 769 days, which period is added to the ordinary expiration date of 7 May 2040 to extend the duration of the US patent until 15 June 2042. In the lead development program, resomelagon (AP 1189) is used as an add-on to first-line therapy with MTX for the treatment of RA. Ensuring optimal exclusivity in the US for this combination treatment is central to the strategy to fortify SynAct's intellectual property rights with respect to resomelagon (AP189). Tillkännagivande • Apr 11
SynAct Pharma AB Announces Initiation of Phase II Study with Resomelagon (AP1189) for the Treatment of Patients with Dengue SynAct Pharma AB announced that the RESOVIR-2 study, an exploratory Phase 2 trial to evaluate the safety and efficacy of the company's lead candidate drug resomelagon (AP1189) in patients with Dengue has been initiated at clinical sites in Brazil. Dengue is a viral infection that spreads from mosquitoes to people. It is more common in tropical and subtropical climates but has spread in recent years also to Europe and the US - probably due to global warming. The most common symptoms are high fever, headache, body aches, nausea, and rash. In a subset of patients, the disease can develop into a critical phase characterized by bleeding, organ dysfunction and hemodynamic shock. When symptoms are present no current specific pharmacological treatment is available. RESOVIR-2 is a randomized placebo-controlled, phase II study testing once daily oral dosing of Resomelagon (AP11 89) vs placebo (1:1 randomization, n=120) as add on to standard treatment in patients with symptomatic Dengue. The potential treatment effect of resomelagon will be evaluated by time to disease resolution though a composite clinical end point. Secondary clinical end points include the ability to reduce the incidence of warning signs of and/or the development of severe dengue. The study is initiated and led by Professor Mauro Teixeira, MD, PhD Universidade Federal de Minas Gerais (UFMG), Belo Horizonte at clinical sites in Brazil. Recruitment to and completion of the study depends on the severity of this year's Dengue epidemic at sites. The RESOVIR collaboration setup evaluate the potential of resomelagon and potential other pro-resolving compounds as host-directed therapy for treatment of severe viral infections. Following on to RESOVIR-1 that showed clinical proof-of-concept in COVID-19 patients RESOVIR-2 could add additional clinical proof-of-concept for the effect of resomelagon for resolving inflammation in patients with severe viral infections. Tillkännagivande • Mar 18
SynAct Pharma AB (publ) Announces European Patent Office Issues an Intention to Grant a European Patent Covering the Clinical Formulation of Resomelagon (AP1189) SynAct Pharma AB (publ) announced that the European Patent Office (EPO) on 14 March 2025 has issued an intention to grant of a European Patent with claims covering the formulation of resomelagon (AP1189) currently undergoing development in clinical phase 2b. In addition to the US patent recently issued covering the specific salt form under clinical development, the present European patent will issue in a complementary patent family covering the formulation of these salt forms and as such will fortify the protection of resomelagon and the drug product in development. The formulation patent will provide exclusivity in Europe for SynAct's lead asset until 2042 in all uses. In brief, an "Intention to grant" means that the EPO intends to grant a European patent based on the patent application as currently on file and a final "Decision to grant" will be issued by the EPO when all formalities are adhered to. After grant the European patent will be converted into national rights in European jurisdictions. Tillkännagivande • Jan 09
SynAct Pharma AB has completed a Follow-on Equity Offering in the amount of SEK 19.845245 million. SynAct Pharma AB has completed a Follow-on Equity Offering in the amount of SEK 19.845245 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 2,294,248
Price\Range: SEK 8.65
Transaction Features: Rights Offering Tillkännagivande • Nov 29
SynAct Pharma AB, Annual General Meeting, May 29, 2025 SynAct Pharma AB, Annual General Meeting, May 29, 2025. Tillkännagivande • Nov 27
SynAct Pharma AB Receives EU Trial Approval for the Phase 2b Advance Study with Resomelagon (AP1189) SynAct Pharma AB announced that the company has received clinical trial approval in the EU for the Phase 2b ADVANCE study in newly diagnosed severe rheumatoid arthritis (RA) patients with the lead compound resomelagon (AP1189). Recruitment and dosing of patients is already underway in the US and Moldova. The study is set up as double-blind placebo-controlled Phase 2b study with the aim to test three doses of the lead compound resomelagon (AP1189) versus placebo in combination with methotrexate as a new patient friendly first-line treatment option in RA. Resomelagon (AP1189) is a biased melanocortin receptor type 1 and 3 agonist for once daily oral dosing. The compound induces resolution rather that suppression of system meaning that the compound has the potential to be an effective oral agent for early intervention in RA without the safety risks of immune suppression common to other therapies. The primary aim of the ADVANCE study is to confirm the treatment potential of the compound, previously reported in the BEGIN study and in the subset of newly diagnosed patients with sign of systemic inflammation in the EXPAND study, and to identify optimal doses for Phase 3 development in patients with newly diagnosed RA. In the ADVANCE study four groups of RA patients, diagnosed within 6 months and showing signs of severe RA (DAS28-CRP >5.1; CDAI >22) including signs of systemic inflammation, defined as hsCRP to be above normal range (>3 mg/L) are given either placebo or one of three doses of resomelagon (40, 70, 100 mg) once daily for 12 weeks in combination with MTX treatment. The study is designed to randomize 240 patients using treatment induced reduction in DAS28-CRP as the primary efficacy readout in line with the current guidelines from FDA and EMA. The aim is to have enrolment and dosing of all patients completed in Fourth Quarter 2025. Tillkännagivande • Oct 29
SynAct Pharma AB to Report Fiscal Year 2024 Results on Feb 18, 2025 SynAct Pharma AB announced that they will report fiscal year 2024 results on Feb 18, 2025 Tillkännagivande • Sep 26
SynAct Pharma AB Initiates the Phase 2b Advance Study with Resomelagon (AP1189) in the US SynAct Pharma AB announced that the ADVANCE study, a Phase 2b randomized, double-blind placebo controlled clinical multi-center study in patients with newly diagnosed severe rheumatoid arthritis (RA) with the company's lead compound resomelagon (AP1189) actively recruits patients following initiation of sites in the USA. Resomelagon (AP1189) is a biased melanocortin receptor type 1 and 3 agonist that in Phase 2 clinical trials in newly diagnosed RA patients with high disease activity and signs of systemic inflammation showed significant treatment effect compared to placebo treatment with a good safety profile supporting first line treatment with the compound in combination with methotrexate (MTX). The primary aim of the ADVANCE study is to confirm the treatment potential of the compound and to identify optimal doses for Phase 3 development in patients with newly diagnosed RA. In the ADVANCE study four cohorts of RA patients, diagnosed within 6 months and showing signs of severe RA (DAS28-CRP >5.1; CDAI >22) including signs of systemic inflammation, defined as hsCRP to be above normal range (>3 mg/L) are given either placebo or one of three doses of resomelagon (40, 70, 100 mg) once daily for 12 weeks in combination with MTX treatment. The study is designed to randomize 240 patients using treatment induced reduction in DAS28-CRP as the primary efficacy readout in line with the current guidelines from FDA and EMA. The study will be conducted at clinical sites in the US and in Europe with enrolment of all patients planned to be completed in Fourth Quarter 2025. New Risk • Aug 21
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr82m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr82m free cash flow). Earnings have declined by 46% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (8.0% average weekly change). Shareholders have been diluted in the past year (30% increase in shares outstanding). Market cap is less than US$100m (€28.3m market cap, or US$31.5m). Tillkännagivande • Jul 01
SynAct Pharma AB Initiates Filing Process for Phase 2b Advance Study with Resomelagon SynAct Pharma AB announced it has initiated the filing process with submission in the US for a Phase 2b randomized, double-blind placebo controlled clinical multi-center study with the company's lead compound resomelagon (AP1189) to be conducted at sites in the US and in Europe. Resomelagon is a biased melanocortin receptor type 1 and 3 agonist that in Phase 2 clinical trials in newly diagnosed RA patients with high disease activity and signs of systemic inflammation showed significant treatment effect compared to placebo treatment with a good safety profile supporting first line treatment with the compound in combination with methotrexate (MTX). The primary aim of the ADVANCE study is therefore to confirm the treatment potential of the compound and to identify optimal doses for Phase 3 development in patients with severe newly diagnosed RA. The ADVANCE study is set up as a double-blind placebo controlled multi-center study testing three doses of resomelagon (40, 70, 100 mg) given once daily for 12 weeks in combination with MTX treatment in patients showing signs of severe RA (DAS28-CPR >5.1; CDAI >22) including signs of systemic inflammation defined as hsCPR to be above normal range (>3 mg/L). The study is designed to randomize 240 patients using treatment induced reduction in DAS28-CRP as the primary efficacy readout in complete accordance with the current guidelines from FDA and EMA. The study will be conducted at clinical sites in the US and in Europe. The submission in the US will be followed by submission of clinical trials applications in Europe in the upcoming weeks. It is the intention to have active recruitment up running in late third quarter 2024 with enrolment of all patients to be completed in fourth quarter 2025. Recent Insider Transactions • May 10
Chief Operating Officer recently bought €160k worth of stock On the 8th of May, Thomas Boesen bought around 19k shares on-market at roughly €8.60 per share. This trade did not impact their existing holding. This was the largest purchase by an insider in the last 3 months. Thomas has been a buyer over the last 12 months, purchasing a net total of €163k worth in shares. Tillkännagivande • May 01
SynAct Pharma AB has completed a Follow-on Equity Offering in the amount of SEK 49.239162 million. SynAct Pharma AB has completed a Follow-on Equity Offering in the amount of SEK 49.239162 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 5,399,999
Price\Range: SEK 8.6
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 236,742
Price\Range: SEK 8.6
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 88,743
Price\Range: SEK 8.6
Transaction Features: Subsequent Direct Listing Tillkännagivande • Mar 27
SynAct Pharma AB has filed a Follow-on Equity Offering in the amount of SEK 45 million. SynAct Pharma AB has filed a Follow-on Equity Offering in the amount of SEK 45 million.
Security Name: Shares
Security Type: Common Stock
Transaction Features: Subsequent Direct Listing Tillkännagivande • Mar 23
SynAct Pharma AB Announces CEO Changes SynAct Pharma AB announced Jeppe Øvlesen was appointed as new CEO succeeding Torbjørn Bjerke effective immediately due to a disagreement over the company's strategy. Jeppe Øvlesen, born 1962, is an experienced executive and biotech entrepreneur with a strong commercial background and a solid deal-making track record. He has more than 20 years of experience at the executive level and has been involved in a string of successful start-up companies, including Action Pharma, Perfusion Tech, CLC Bio, Cercare Medical, ChemoMetec, Cetrea, Monsenso, PNN Medical, Mindway, ResoTher Pharma, Go Pen, Neurescue and TXP Pharma. From 2015 to 2023 Øvlesen was the CEO of SynAct Pharma. Mr. Øvlesen has an MBA with a focus on leadership and finance from the University of Hartford, US. He is currently chairman in HG Energy Group A/S, Cercare Medical A/S, Go-Pen A/S, and Neurescue ApS, and is a board member in Perfusion Tech Aps, ResoTher Pharma Aps, Cereno Scientific and SynAct Pharma. Tillkännagivande • Mar 22
SynAct Pharma AB Elects New Board Members and Chairman at Extraordinary General Meeting SynAct Pharma AB announced at its extraordinary general meeting held on March 20, 2024, Anders Kronborg, Sten Scheibye, Sten Sørensen, and Jeppe Øvlesen was elected new members of the board. Anders Kronborg was elected chairman of the board of directors. Tillkännagivande • Mar 12
SynAct Pharma AB Announces Outcomes of the Independent Audit of the 4-Week Resolve P2a Clinical Trial in Rheumatoid Arthritis SynAct Pharma AB reported that during the evaluation of the data from part A of the RESOLVE study, a four-week dose range study of resomelagon (AP1189) in rheumatoid arthritis patients with an inadequate response to methotrexate treatment, issues were identified that needed further evaluation and initiated an audit of the study by an independent third-party auditor. The independent audit has identified that safety data from all sites should be included in the product safety base and that drug exposure and efficacy data could be utilized for further assessment except for the data from one site where drug exposure and efficacy data should be excluded. The analyses of the study identified a large degree of heterogeneity in the recruited patient population. Two-thirds of the patients had been on methotrexate (MTX) treatment for more than one year at the time of recruitment, with most patients being treated for over 2 years with only 5 completed patients having a medical history of initiation of MTX treatment within 6 months of RA diagnosis. In addition, medical history, as reported, did not support treatment with maximal tolerable dose of methotrexate in a fraction of the recruited patients. In total 125 patients were included of which 107 completed Resolve Part A per protocol with daily doses of placebo, 60mg, 80mg or 100 mg resomelagon for 4 weeks in addition to a stable dose of MTX. As efficacy data from one site has to be excluded from the efficacy analyses, SynAct is awaiting final efficacy assessments from the contract research organization (CRO) with the site removed from the calculations. However, the study showed a very high placebo effect with ACR20, the primary efficacy readout, around 50% at 1-month and with lower numbers reached in the three active groups. Resomelagon continued to be generally safe and well tolerated relative to placebo. One serious adverse event (SAE) was reported in the study in a placebo treated patient that was hospitalized due to severe exacerbation in joint pain. The total number of treatment emergent adverse events (TEAEs) reported was 56 in the 125 recruited patients with 16 in the placebo group and 10, 12 and 18 in the 60mg, 80mg and 100mg resomelagon groups, respectively. As Resolve Part A was not able to identify doses of resomelagon to be applied in part B of the RESOLVE study. a 12-week Phase 2b study in DMARD-IR patients will be postponed until the compound has been tested in the relevant patients, O tested as a 12-week second line treatment option in RA patients showing an incomplete response to their initial course of MTX treatment, primary DMARD-IR. The company is in discussion with the CRO who ran the Resolve Part A study as a full service CRO with the aim to get the study duly reported and the project back on track in the most effective way. Tillkännagivande • Feb 28
SynAct Pharma AB (publ) Announces Resignation of Marina Bozilenko as Member of the Board of Directors SynAct Pharma AB (publ) announced Marina Bozilenko has notified the Board of her resignation as member of the Board of Directors due to personal reasons. New Risk • Feb 25
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr100m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr100m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr181m net loss in 2 years). Shareholders have been diluted in the past year (12% increase in shares outstanding). Market cap is less than US$100m (€26.5m market cap, or US$28.6m). Tillkännagivande • Feb 22
SynAct Pharma Announces Additional Data from the Expand P2b Clinical Trial Supporting Continued Development of the Compound in Rheumatoid Arthritis SynAct Pharma announced additional data from the EXPAND P2b clinical trial supporting continued development of the compound in rheumatoid arthritis. SynAct previously released a post-hoc analysis of the EXPAND trial of once-daily oral resomelagon in treatment naive rheumatoid arthritis patients who had an elevated baseline level of C-reactive protein (CRP> 3mg/L), marker of systemic inflammation. To further this assessment, a subset analysis of the elevated baseline CRP patients who were enrolled within 6 months of their diagnosis of rheumatoid arthritis (RA) was conducted. In this subpopulation of patients, 100mg of daily resomelagon demonstrated a consistent and statistically significant response to therapy over placebo across assessed outcome measures. At 12 weeks in EXPAND patients with elevated baseline CRP, the 100mg resomelagon group had an ACR20 attainment of 71% as compared to 54% of placebo patients. At 12 weeks in the subpopulation of patients with elevated CRP who were enrolled and had treatment initiated within 6mo of their RA diagnosis, 23 out of 28 (82%) of patients treated with 100mg resomelagon attained an ACR20 compared to 14 out of 27 (52%) of placebo patients (P<0.05). A significant difference favoring resomelagon was also seen across the secondary outcome measures including the reduction in CDAI (resomelagon 24.6 vs placebo 14.7 points, p<0.01), reduction in DAS28-CRP (resomelagon 1.9 vs placebo 1.2 points, p<0.001), and reduction in HAQ disability index (0.69 vs placebo 0.31 points, p<0.05). Safety in the elevated CRP population with treatment within 6 months of was comparable to what has been previously reported for the full EXPAND study population. Tillkännagivande • Feb 10
SynAct Pharma AB to Report Q4, 2023 Results on Feb 23, 2024 SynAct Pharma AB announced that they will report Q4, 2023 results at 7:30 AM, Central European Standard Time on Feb 23, 2024 Board Change • Feb 02
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 4 experienced directors. 1 highly experienced director. Chief Scientific Officer & Director Thomas Jonassen is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Tillkännagivande • Feb 01
Synact Pharma Appoints Kristen Harting as Chief Medical Officer, Effective 15 February 2024 SynAct Pharma AB announced the appointment of Kristen Harting, MD, as Chief Medical Officer (CMO), effective 15 February 2024. She will lead all clinical development and medical affairs and report to the CEO. Harting brings more than 30 years’ experience to the SynAct team and the company’s push to advance the lead drug candidate resomelagon and its TXP peptide agonists. Harting joins SynAct following more than three decades within big pharma and biotech as a chief medical officer. She has in-depth knowledge about development with comprehensive early and late clinical phase experience, including the approval of new medicines, combined with business insights. Harting is currently CMO at both Alzinova and Tetra Pharm Technologies and is Medical & Compliance Manager at Sandoz. Kristen Harting earned her MD from the University of Copenhagen and her Executive MBA from the Copenhagen Business School. Tillkännagivande • Jan 30
Synact Pharma Expands Its Rheumatology Clinical Advisory Board with Three New Highly Experienced Advisors SynAct Pharma AB announced the addition of three distinguished rheumatologists to its Rheumatology Clinical Advisory Board. The new Board members have agreed to join the panel to help guide SynAct in the development of resomelagon in RA and potentially other diseases. New members of SynAct’s Rheumatology Clinical Advisory Board: Roy Fleischmann, MD, MACR, Ravi Rao, MD, PhD and Vibeke Strand, MD, FACP, MACR. Roy Fleischmann, MD, MACR – Master of the American College of Rheumatology and a Clinical Professor of Medicine at the University of Texas Southwestern Medical Center, Co- Medical Director of the Metroplex Clinical Research Center and Division of Rheumatology at the Presbyterian Medical Center in Dallas. He is an Overseas Fellow of the Royal Society of Medicine, a past President of the Texas Rheumatism Association, Division Director Rheumatology, St, Paul Medical Center. He has been involved in the clinical development of most medications approved for rheumatic disease in the US. He has published over 300 peer-reviewed manuscripts and presented over 500 abstracts at major Rheumatology meetings on disease management and drug development. Ravi Rao, MD, PhD – Currently CMO at Sitryx Therapeutics and Venture Partner at SV Health Investors; previously a Consultant Rheumatologist at Imperial College NHS Trust, Roche: Medical Director, Immunology Clinical Development, GSK: VP, Global Medical Head, Immunology-inflammation and Future Pipeline Franchise, SOBI: Head R&D and CMO. Vibeke Strand, MD, FACP, MACR - Adjunct clinical professor in the Division of Immunology and Rheumatology at Stanford University School of Medicine since 1993, previously Assistant and Associate Clinical Professor of Rheumatology at UCSF. Since 1991, she has led a consulting practice offering clinical research and regulatory strategy expertise to pharmaceutical and biotech companies. She has participated in the successful development of csDMARDs, biologics and JAK inhibitors in RA, including working with FDA, CDER, CBER and CDRH. She is a co-founder and member of the Executive Organizing Committee of the international Outcomes in Rheumatology [OMERACT] consensus conferences [1992 – present] which develop and validate outcome measures for use in RCTs and longitudinal observational studies. Vibeke Strand has authored > 500 peer-reviewed publications. Tillkännagivande • Nov 02
SynAct Pharma AB has completed a Follow-on Equity Offering in the amount of SEK 60.525 million. SynAct Pharma AB has completed a Follow-on Equity Offering in the amount of SEK 60.525 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 3,750,000
Price\Range: SEK 16.14
Transaction Features: Subsequent Direct Listing Tillkännagivande • Nov 01
SynAct Pharma AB Announces Evaluation of the 4-Week RESOLVE P2a Clinical Trial in Moderate to Severe Active Rheumatoid Arthritis Patients with an incomplete Response to Methotrexate SynAct Pharma AB reported update from the 4-week RESOLVE P2a study of three doses of once-daily oral resomelagon (AP1189) in rheumatoid arthritis (RA) patients experiencing an incomplete response to methotrexate (MTX) therapy. Unblinded data from the study identified multiple irregularities in the conduct of the study and SynAct Pharma therefore needs to investigate the quality of the study in much more detail before making any conclusion on the results. Tillkännagivande • Oct 05
SynAct Pharma AB Announces Additional Data from the Expands P2b Clinical Trial Further Supporting Efficacy and Activity seen in Patients with Elevated CRP SynAct Pharma AB reported additional results from the 12-week Phase 2b EXPAND study of 100mg once-daily oral resomelagon (AP1189) in newly diagnosed rheumatoid arthritis (RA) patients experiencing severe disease activity. SynAct previously announced that while the overall study did not achieve its primary endpoint, resomelagon treatment demonstrated consistent efficacy and activity over placebo in patients with elevated CRP levels (>3mg/L) at baseline as evidenced by a 70.6% ACR20 response rate at 12 weeks vs 54.3% in the placebo group. Today's release adds more detailed data on the HAQ disability index, data from the sub-study of MRI imaging of wrist and hand joints and biomarker data all supporting resomelagon efficacy and activity in this important and relevant patient population. SynAct previously announced that in patients with baseline CRP >3mg/L at baseline treated with resomelagon had an average decrease in their HAQ-DI score of 0.64 which is almost 3 times the minimal clinically important difference (MCID). release indicates that the HAQ-DI sections showing the largest mean disability improvements over placebo relate to improvements in hand strength and dexterity. Resomelagon treated patients reported a 50% improvement in activates relating to eating, 43% in dressing and grooming and 38% in grip as compared to 24%, 25% and 18% respectively for placebo. A sub study using contrast-enhanced MRI to assess joint inflammation in patients with inflamed wrist and hand joints was conducted in 23 patients treated with placebo. 74% of the resomelagon patients had CRP>3 mg/L at baseline compared to 33% in the placebo group. The MRI techniques used measure the peak enhancement and rate of enhancement of a contrast agent as indicators of synovial inflammation. Comparing the 12 weeks MRI with the Baseline MRI the resomelagon group showed a larger reduction in both mean peak enhancement (3.8 ml vs 1.2 ml) and mean initial rate of enhancement (0.06 ml/sec vs 0.01 ml/sec) indicating a greater reduction in inflammation intensity. Activation of these receptors can result in both anti-inflammatory effects like lowering the level of pro-inflammatory molecules and in pro-resolution effects like switching macrophages to perform inflammation 'clean-up', known as efferocytosis (J Immun 2015, 194: 3381-3388). This dual effect has shown to be effective in disease models of inflammatory and autoimmune diseases and the clinical potential of the approach is currently tested in clinical programs in patients with rheumatoid arthritis (ra). Tillkännagivande • Sep 13
SynAct Pharma AB Announces Additional Data from the EXPAND P2b Clinical Trial and Identifies Population with Responsiveness to Resomelagon SynAct Pharma AB reported additional data from the 12-week P2b EXPAND study of 100mg once- daily oral resomelagon (AP1189) in newly diagnosed rheumatoid arthritis (RA) patients experiencing severe disease activity. SynAct previously announced that the study did not meet the primary endpoint of a significantly higher ACR20 response at 12 weeks as compared to placebo. This release identifies a patient population with active systemic inflammation, where resomelagon demonstrated activity over placebo on the ACR20 primary endpoint as well as all other assessed secondary outcome measures. SynAct management will hold a webcast to discuss this announcement later (details below). The EXPAND (SynAct-CS007) study was a multicenter, randomized, double-blind, placebo- controlled, 12-week study in newly diagnosed, treatment naïve patients with highly active RA (Clinical Disease Activity Score (CDAI) > 22) conducted in sites in Bulgaria and Moldova. 127 patients presenting with high disease activity (CDAI > 22) were randomized 1:1 for treatment with once daily 100 mg resomelagon or placebo added to a background of methotrexate (MTX) therapy. In patients with baseline CRP levels of >3mg/L (c-reactive protein, a blood marker of systemic inflammation, 61% of the full study population), resomelagon demonstrated consistent activity over placebo with 70.6% of resomelagon treated patients achieving an ACR20 response at 12weeks compared to 54.3% of patients on placebo. Similar strong trends favoring resomelagon treatment were seen across the individual ACR component scores as well as other key secondary outcome measures including reduction in Clinical disease activity index (CDAI) and disease activity evaluated by Disease Activity Score (DAS28). The HAQ score, a self-assessment of patient physical ability that is a component of ACR scoring, demonstrated at 12 weeks that resomelagon treated patients achieved a 60% higher improvement over placebo treatment. This assessment adds to the previously announced favorable safety and tolerability profile of resomelagon. Resomelagon (AP1189), is a once-daily oral selective melanocortin agonist that selectively activates melanocortin receptors 1 and 3 that are directly involved in inflammation and its resolution. These receptors are located on immune cell types including macrophages and neutrophils. Activation of these receptors can result in both anti-inflammatory effects like lowering the level of pro-inflammatory molecules and in pro-resolution effects like switching macrophages to perform inflammation `clean-up', known as efferocytosis (J Immun 2015, 194: 3381-3388). This dual effect has shown to be effective in disease models of inflammatory and autoimmune diseases and the clinical potential of the approach is currently tested in clinical programs in patients with rheumatoid arthritis (RA). The EXPAND (SynAct-CS007) study is a multicenter, randomized, double-blind, placebo-controlled, 12-week study in newly diagnosed, treatment naïve patients with highly active RA (Clinical Disease Activity Score (CDAI) > 22) In EXPAND, 127 RA patients with high disease activity (CDAI > 22) were randomized 1:1 for treatment with either 100 mg resomelagon (AP1189) tablets or placebo tablets for a once daily dose for 12 weeks, concurrently with the initiation of dosing with methotrexate. The primary efficacy read-out in the EXPAND is proportion of patients achieving 20% improvement in ACR (ACR20) at week 12 relative to placebo. The safety evaluation included adverse event monitoring, biochemical and hematological evaluation, physical examinations, and vital sign measurements. In addition, several secondary efficacy endpoints are defined, including, ACR50, ACR70, CDAI, and Disease activity score 28 (DAS-28) change over time, Change in Health Assessment Questionnaire Disability Index (HAQ-DI) and Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue), as well as use of corticosteroids as rescue medication. Tertiary endpoints are included to further explore the effect of resomelagon (AP1189) on biomarkers and by evaluation of synovial inflammation using magnetic resonance imaging (MRI). Tillkännagivande • Sep 05
Synact Pharma Announces Top Line Data from the 12-Week Expand P2b Clinical Trial in Severe Active Newly Diagnosed Rheumatoid Arthritis Patients SynAct Pharma AB SynAct Pharma AB reported topline results from the 12-week P2b EXPAND study of 100mg once-daily oral resomelagon (AP1189) in newly diagnosed rheumatoid arthritis (RA) patients experiencing severe disease activity. The study did not meet its primary endpoint of significance over placebo with the ACR20 outcome. Although resomelagon did not demonstrate a clear clinical benefit on the primary endpoint it continued to demonstrate a favorable safety profile. Objectives measures of activity in the EXPAND trial were more in-line with the BEGIN study. SynAct management will hold a webcast to discuss this announcement later today (details below). The EXPAND (SynAct-CS007) study was a multicenter, randomized, double-blind, placebo- controlled, 12-week study in newly diagnosed, treatment naïve patients with highly active RA (Clinical Disease Activity Score (CDAI) > 22) conducted in sites in Bulgaria and Moldova. 127 patients presenting with high disease activity (CDAI > 22) were randomized 1:1 for treatmentwith once daily 100 mg resomelagon or placebo added to a background of methotrexate (MTX) therapy. 54.7% of patients treated with 100mg of once-daily oral resomelagon achieved an ACR20 response at 12-weeks as compared to 55.7% of patients receiving placebo. This unexpected finding in part was driven by high placebo responses linked to the subjective component measures of the ACR scoring system. SynAct continues to assess this top-line study data to better understand these results. Resomelagon continued to demonstrate a favorable safety profile in this high activity patient population. The overall rate of treatment emergent serious adverse events (SAEs) was 1.6% (n=2), with 1 SAE in each group. The overall rate of patients experiencing treatment emergent adverse events (AEs) was 44.4% and 42.2% for resomelagon and placebo treated patients respectively (all patients received MTX). There were no observed signs of immunosuppression seen in the resomelagon group over that associated with background methotrexate therapy. Tillkännagivande • Aug 18
SynAct Pharma AB (Publ) Completes Dosing in Part A of Combined Phase 2A/B Resomelagon (AP1189) in Rheumatoid Arthritis (RA) SynAct Pharma AB (publ) announced that dosing has been completed in the Phase 2a portion of the RESOLVE Phase 2a/b clinical study of once-daily oral resomelagon (AP1189) in patients with an inadequate response to first-line disease-modifying antirheumatic drugs (DMARD-IR). A total of 125 patients were randomized into the study with over 20% recruited in the US. With dosing completed SynAct anticipates releasing top-line study data in October of this year. Development of resomelagon in DMARD-IR patients is being done under an IND (Investigational New Drug) application with clinical sites in the both the US and in European countries. RESOLVE is designed in two parts with a 4 week Phase 2a dose selection and initial safety and efficacy assessment portion that will enable dose selection for the 12 week Phase 2b safety and efficacy assessment. Planning and preparation for the Phase 2b study, i.e. part B of the FDA approved RESOLVE protocol, has begun. RESOLVE (AP1189), is a once-daily oral melanocortin agonist that selectively activates melanocortin receptors 1 and 3 that are directly involved in inflammation and its resolution. These receptors are located on immune cells including macrophages and neutrophils. Activation of these receptors can result in both anti-inflammatory effects like lowering the level of pro- inflammatory molecules and in pro-resolution effects like switching macrophages to perform inflammation 'clean-up', known as efferocytosis (J Immun 2015, 194:3381-3388). This dual effect has shown to be effective in disease models of inflammatory and autoimmune diseases and the clinical potential of the approach is currently tested in clinical programs in patients with rheumatoid arthritis (RA). The RESOLVE Phase 2a portion of theRESOLVE study was designed to enable effective dose selection for the Phase 2b study and to obtain proof of concept data on the safety and efficacy or resomelagon in this important patient population. The Phase 2a study was not powered to demonstrate a statistically significant difference between active and placebo groups. A total of 125 patients with moderate to severely active RA despite an adequate course of MTX therapy were randomized to treatment with either resomelagon dosed at 60 mg, 80 mg, or 100 mg or with placebo once daily for 4 weeks as add-on treatment to stable background MTX treatment. In the Phase 2b portion of the RESOLVE study, patients will be randomized into up to 3 resomelagon dose groups or placebo, all administered once daily for 12 weeks as add-on treatment To stable background MTX treatment. The total study population may be up to 300 patients, depending on the number of dose groups of resomelagon selected for evaluation. The objectives of the RESOLVE study are to evaluate the efficacy and safety of resomelagon vs placebo when added to background MTX therapy in DMARD-IR patients. Tillkännagivande • Jul 22
SynAct Pharma AB (publ) Completes Patient Recruitment for Part A of Combined Phase 2a/b RESOLVE Study of Resomelagon (AP1189) in Rheumatoid Arthritis SynAct Pharma AB (publ) announced that it completed patient recruitment for part A of the P2a/b RESOLVE clinical study of resomelagon (AP1189) in patients with an inadequate response to first-line disease modifying anti- rheumatic drugs (DMARD-IR) who are experiencing moderate to severe disease activity. With all patients recruited SynAct anticipates releasing top-line study data in October this year. Development of resomelagon (AP1189) in DMARD-IR patients is done under an IND (Investigational New Drug) application with clinical sites in the both the US and in European countries. The clinical study RESOLVE is designed as a two-part safety and dose finding study with four weeks dosing in part A like in the BEGIN study, followed by a part B resembling the clinical study EXPAND with 12 weeks once daily dosing. Planning for part B has started and more information will be shared as the study progresses. Tillkännagivande • Jul 14
SynAct Pharma AB (publ) Announces the Completion of Dosing in the Phase 2b Expand Study of Resomelagon (AP1189) in Early Severe Rheumatoid Arthritis Patients SynAct Pharma AB (publ) announced that dosing has been completed in the company's 12-week EXPAND Phase 2b clinical trial evaluating once-daily resomelagon (AP1189) in early rheumatoid arthritis (RA) patients with severe disease. SynAct anticipates being able to release top-line study data in September. The EXPAND study builds upon the BEGIN phase 2a RA study where resomelagon (AP 1189) demonstrated the ability to induce a significant and clinical meaningful reduction in patient disease activity when compared to placebo through 4 weeks of treatment. In both the BEGIN and EXPAND trials, resomelagon (AP1289) is given in combination with the first-line treatment methotrexate in treatment naive patients with severely active RA. The mechanism of action of resomelagon (AP1489), is to promote resolution of inflammation through selective activation of melanocortin receptors 1 and 3. These receptors are located on all immune cell types including macrophages and neutrophils. Activation of these receptors can result in both anti-inflammatory effects like lowering the level of pro-inflammatory molecules and in pro-resolution effects like switching macrophages to perform inflammation "clean-up", known as efferocytosis (J Immun 2015, 194:3381-3388). This dual effect has shown to be effective in disease models of inflammatory and autoimmune diseases and the clinical potential of the approach is currently tested in clinical programs in patients with rheumatoid arthritis (ra), nephrotic syndrome (NS) and COVID-19. The EXPAND (SynAct-CS007) study is a multicenter, randomized, double-blind, placebo-controlled, 12-week study in newly diagnosed, treatment naive patients with highly active RA (Clinical Disease Activity Score (CDAI) > 22) In EXPAND, approximately 120 RA patients with high disease activity (CDAI > 22) will be randomized 1:1 for treatment with either 100 mg resomelagon (AP1089) tablets or placebo tablets for a once daily dose for 12 weeks, concurrently with the initiation of dosing with methotrexate. The primary efficacy read-out in the EXPAND is proportion of patients achieving 20% improvement in ACR (ACR20) at week 12 relative to placebo. The safety evaluation read-outs include adverse event monitoring, biochemical and hematological evaluation, physical examinations, and vital sign measurements. In addition, several secondary efficacy endpoints are defined, including, ACR50, ACR70, CDAI, and Disease activity score 28 (DAS-28) change over time, Change in Health Assessment Questionnaire Disability Index (HAQ-DI) and Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue), as well as use of corticosteroids as rescue medication. Tertiary endpoints are included to further explore the effect of resomelagon (AP1189) on biomarkers and by evaluation of synovial inflammation using magnetic resonance imaging (MRI). Tillkännagivande • May 27
SynAct Pharma AB Announces Appointment of Thomas Von Koch as Board Member SynAct Pharma AB announced appointment of Thomas Von Koch as new board member, at its AGM held on May 25, 2023. Tillkännagivande • May 17
SynAct Pharma AB Appoints Björn Westberg as Chief Financial Officer SynAct Pharma AB (publ) announced that Björn Westberg has been appointed Chief Financial Officer and member of the management team at SynAct. Björn has extensive experience from the life science sector, from smaller pharmaceutical companies to contract manufacturing and "Big Pharma". He served as a CFO of several listed companies and most recently comes from his role as CFO at Attgeno. Björn has more than 25 years of experience in the life science sector and has served as a chief financial officer since 2001. Prior to his role at privately held Attgeno, he was CFO at global cloud software company Enea, Swedish medtech Bonesupport, both of which are listed on Nasdaq Stockholm, and pharmaceutical developer and manufacturer Recipharm. He started his career at AstraZeneca where he worked in various capacities from 1989-2001. Björn Westberg will take up the position full-time from August 16. He will formally start his position as CFO part-time on June 15, and replace Patrik Renblad who announced his resignation in February. Board Change • Feb 23
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Kerstin Hasselgren was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Board Change • Feb 02
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Kerstin Hasselgren was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Board Change • Jan 20
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Kerstin Hasselgren was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Jan 18
SynAct Pharma AB (OM:SYNACT) completed the acquisition of TXP Pharma AG from Boesen Biotech ApS, GL Capital AB, TJ Biotech Holding ApS, Quantass ApS, and James Knight. SynAct Pharma AB (OM:SYNACT) entered into a conditional agreement to acquire TXP Pharma AG from Boesen Biotech ApS, GL Capital AB, TJ Biotech Holding ApS, Quantass ApS, and James Knight for approximately SEK 190 million on December 12, 2022. The purchase price consists of a fixed purchase price of SEK 136 million and a potential additional purchase price of SEK 55 million, where the fixed purchase price is paid through 2,172,523 newly issued shares in SynAct. The additional purchase price is a one-time amount of SEK 55 million which will be payable if (i) SynAct’s board of directors, following the completion of the first Phase II study with one of TXP’s compounds, resolves to continue the development of said compound for a subsequent Phase IIb or a Phase III study or if an application to commence such studies is filed; TXP divests or licenses one of TXP’s compounds; or SynAct divests the shares in TXP. The additional purchase price shall only be payable once upon the first fulfilment of any of the events entitling to the additional purchase price. The sellers of TXP have undertaken, with certain customary exceptions, not to sell the newly issued shares received as considerations during a period of 90 days after the closing date. Subject to the extraordinary general meeting resolving to approve the acquisition and the issue of the consideration shares, the acquisition of TXP is expected to be completed around January 16, 2023. The transaction process has been handled by a committee composed of the four non-conflicted members of the board of directors, chaired by Uli Hacksell. As of January 12, 2023, the transaction has been approved by the shareholders of SynAct Pharma. Ernst & Young Corporate Finance AB acted as fairness opinion provider, Van Lanschot Kempen N.V. acted as financial advisor, and Setterwalls Advokatbyrå AB and BGPartner AG are acted as legal advisors to SynAct.
SynAct Pharma AB (OM:SYNACT) completed the acquisition of TXP Pharma AG from Boesen Biotech ApS, GL Capital AB, TJ Biotech Holding ApS, Quantass ApS, and James Knight on January 16, 2023. Tillkännagivande • Dec 22
SynAct Pharma AB Announces Change in Nomination Committee Prior to Agm 2023 SynAct Pharma AB announced that the composition of the Nomination Committee prior to the Annual General Meeting on 25 May 2023 has changed as a result of a change of ownership.Following the change, the Nomination Committee for the 2023 Annual General Meeting consists of the following persons: Niels Ankerstjerne Sloth, appointed by Bioinvest ApS; Per Colleen, appointed by TomEnterprise Public Capital AB; Jens Bager, appointed by GL Capital AB; and Torbjørn Bjerke, Chairman of the Board. Jens Bager remains as Chairman of the Nomination Committee. Recent Insider Transactions • Dec 16
Chief Operating Officer recently sold €317k worth of stock On the 12th of December, Thomas Boesen sold around 43k shares on-market at roughly €7.42 per share. This transaction amounted to 28% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Thomas' only on-market trade for the last 12 months. Tillkännagivande • Dec 14
SynAct Pharma AB (OM:SYNACT) entered into a conditional agreement to acquire TXP Pharma AG from Boesen Biotech Aps, Glcapital Ab, TJ Biotech Holding ApS, Quantass ApS, and James Knight for approximately SEK 190 million. SynAct Pharma AB (OM:SYNACT) entered into a conditional agreement to acquire TXP Pharma AG from Boesen Biotech Aps, Glcapital Ab and TJ Biotech Holding ApS, Quantass ApS, and James Knight for approximately SEK 190 million on December 12, 2022. The purchase price consists of a fixed purchase price of SEK 136 million and a potential additional purchase price of SEK 55 million, where the fixed purchase price is paid through 2,172,523 newly issued shares in SynAct, corresponding to a dilution of approximately 6.8 per cent. The additional purchase price is a one-time amount of SEK 55 million which will be payable if (i) SynAct’s board of directors, following the completion of the first Phase II study with one of TXP’s compounds, resolves to continue the development of said compound for a subsequent Phase IIb or a Phase III study or if an application to commence such studies is filed; TXP divests or licenses one of TXP’s compounds; or SynAct divests the shares in TXP. The additional purchase price shall only be payable once upon the first fulfilment of any of the events entitling to the additional purchase price. In related with the acquisition, SynAct has also resolved to execute a directed cash new issue of SEK 80 million. The completion of the directed cash new issue is not conditional upon the completion of the acquisition of TXP. The transaction process has been handled by a committee composed of the four non-conflicted members of the board of directors, chaired by Uli Hacksell. In its work, the committee has been supported by legal and financial advisors and has also obtained a third-party valuation of TXP’s assets as well as a so-called fairness opinion issued by Ernst & Young AB. Subject to the extraordinary general meeting resolving to approve the acquisition and the issue of the consideration shares, the acquisition of TXP is expected to be completed around January 16, 2023. Van Lanschot Kempen N.V. is acting as financial advisor to SynAct and Setterwalls Advokatbyrå AB and BGPartner AG are acting as legal advisors to SynAct in connection with the acquisition. Board Change • Nov 21
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Kerstin Hasselgren was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Nov 02
SynAct Pharma AB Receives IND Clearance from the FDA for Phase 2A/B Trial of Ap1189 in Ra SynAct Pharma AB (publ) announced it has received clearance from the US Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for a Phase 2a/b study in Rheumatoid Arthritis (RA) with the company's lead compound AP1189. The IND was submitted to the FDA Division of Rheumatology and Transplant Medicine (DRTM) on September 30, 2022, sponsored by SynAct. On October 31, FDA confirmed by email that as of October 30, 2022, the IND-initiating study, RESOLVE, was safe to proceed. SynAct expects that AP1189, a selective melanocortin receptor agonist, could be very well suited as a once-daily oral treatment therapy for inflammatory and auto-immune diseases, such as RA. AP1189 has been effective, safe and well-tolerated in previous clinical studies. Also, it has a favorable patent situation, with coverage beyond 2040. RESOLVE, which is SynAct's fifth approved clinical Phase 2 study in three different diseases of which two are completed, will be conducted at five clinical sites in the US as well as 12 sites in Bulgaria and Moldova, where Clinical Trial Applications are pending review by the local authorities and ethics committees. The successful outcome of the IND application review implies that SynAct can initiate the clinical development of AP1189 in USA immediately. Tillkännagivande • Oct 22
SynAct Pharma AB, Annual General Meeting, May 25, 2023 SynAct Pharma AB, Annual General Meeting, May 25, 2023. Tillkännagivande • Oct 11
Synact Submits Ind and Recruits First Patient SynAct Pharma is well in line with the communicated plans for the two phase II trials with AP1189 in rheumatoid arthritis - EXPAND and RESOLVE. Most importantly, an IND application has been submitted to the FDA to initiate the RESOLVE study in the US in patients with incomplete response to DMARDs. Another milestone was the enrollment of the first patient in EXPAND, a clinical phase IIb study to investigate the full treatment potential of AP1189 in patients with newly diagnosed rheumatoid arthritis. Tillkännagivande • Oct 01
Synact Pharma Submits IND for US Phase 2A/B Clinical Trial SynAct Pharma AB announced that the company has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), with the aim to commence its Phase 2a/b clinical trial RESOLVE with AP1189 in the United States. The RESOLVE study is a randomized, placebo-controlled, double-blinded, two-part Phase 2a/b clinical study, testing daily treatment of AP1189 in patients with an incomplete response to first-line disease modifying antirheumatic drugs (DMARD), who are experiencing moderate to severe disease activity. A large percentage of patients treated with DMARDs never achieve the full desired effect. Also, they have a diminishing treatment effect or suffer from side effects that can prevent further treatment. These patients who experience an inadequate response to DMARDs are referred to as DMARD-IR (inadequate responder). The company believes that AP1189 could be very well suited for DMARD-IR patients given the emerging profile of an efficacious, safe, and well tolerated once-daily oral therapy. In parallel with the IND application, Clinical Trial Applications (CTAs) are filed in Europe. Subject to regulatory approval from the authorities, the study will be initiated in Fourth Quarter 2022, with the aim of presenting data from the first part in the second half of 2023. Tillkännagivande • Sep 28
SynAct Pharma AB (Publ) Enrolls First Patient in Phase 2b Trial of Ap1189 in RA SynAct Pharma AB (publ) announced enrollment of the first patient to its clinical Phase 2b study EXPAND with the company's candidate drug, AP1189, in patients with newly diagnosed severe rheumatoid arthritis (RA). The EXPAND study, aimed at evaluating the safety and efficacy of SynAct Pharma´s lead compound, AP1189, is now initiated according to plan with recruitment of the first patient in Moldova. Enrollment in Bulgaria will be initiated imminently, following approval from local health authorities and ethical committee earlier this month. The aim of the study is to recruit and treat a total of 120 previous treatment naïve patients with severe RA with once daily dosing of 100 mg AP1189 or matched placebo for 12 weeks given in combination with standard therapy, methotrexate (MTX). In the preceding BEGIN study, AP1189 was found to be safe and well tolerated and induce a statistically significant reduction in disease activity when given once daily for 4 weeks. EXPAND is designed to further evaluate the safety profile and the full treatment potential of the compound when given once daily with the newly developed immediate release tablet during a 12-week treatment period. To strengthen 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, during the study. SynAct expects these data to be pivotal in the interactions with potential partners and for the further development of AP1189. Key results will be available in the second half of 2023, subject to recruitment to the study being conducted as planned. Board Change • Sep 20
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director Kerstin Hasselgren was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Sep 14
SynAct Pharma AB Announces Approval of Amended Study Protocol for the Phase 2A Study in iMN SynAct Pharma AB (publ) announced that the protocol amendment of the ongoing SynAct-CS003 study with the company's candidate drug AP1189 in idiopathic membranous nephropathy (iMN) patients with severe proteinuria and/or Nephrotic Syndrome (NS) has been approved. The company wants to explore the opportunity to treat iMN patients for up to 3 months with AP1189 tablets. Therefore, and as previously communicated, the company submitted a major amendment to the study protocol in July 2022, which has now been approved by the Danish Medicines Agency and is being assessed in Sweden and Norway. The company aims to enroll a minimum of 18 patients to the study and expect to complete and report key results during 2023. Tillkännagivande • Aug 25
SynAct Pharma AB (publ) Announces That the Clinical Trial Application to Initiate the Clinical Phase 2B Study, Expand SynAct Pharma AB (publ) announced that the Clinical Trial Application (CTA) to initiate the clinical Phase 2b study, EXPAND, with the Company’s candidate drug, AP1189, in patients with newly diagnosed rheumatoid arthritis (RA) has been approved in Moldova with the aim to start recruitment of patients as soon as the study sites has been initiated in September. Approval in Bulgaria is expected in the weeks to come. EXPAND is part of SynAct’s strategy to further develop AP1189 as a new oral treatment option in RA. The study is designed to identify the full treatment potential of the compound given in combination with methotrexate (MTX) in previously treatment naïve patients with high disease activity. The purpose of the EXPAND study is to confirm the encouraging effects of AP1189 demonstrated in the BEGIN study, where 100 mg AP1189 once daily for four weeks in combination with MTX treatment was found to be safe and well tolerated and met the primary endpoint of a significantly greater than placebo reduction in clinical disease activity (reduction in CDAI; Placebo: 9.3 points vs 100 mg AP1189: 15.5 points, P<0.05). In addition, treatment with AP1189 was associated with a statistically significant higher proportion of patients achieving 20% improvement in American College of Rheumatology (ACR20) score. (ACR20; Placebo: 33% vs 100 mg AP1189: 61%, P<0.05). Tillkännagivande • Jul 22
SynAct Pharma AB Improves the Design of the Ongoing Phase 2A Study in Imn SynAct Pharma AB (publ) announced that the Company, following protocol redesign, has applied for approval of a major amendment of the ongoing SynAct- CS003 study with the Company's candidate drug AP1189 in idiopathic membranous nephropathy (iMN) patients with severe proteinuria and/or Nephrotic Syndrome (NS). As previously announced, SynAct wants to explore the opportunity to treat iMN patients for up to 3 months with AP1189 tablets. Therefore, the design of the clinical study has been thoroughly reassessed, and input has been taken from leading Nordic experts in iMN. If successful, the redesigned study will support the concept of dosing AP1189 to treat autoimmune and inflammatory diseases, by promoting resolution of the inflammation in a non-suppressive manner by balancing the patients' immune response. As such, SynAct-CS003 will be the third proof of concept study, following positive results of treating COVID-19 induced acute respiratory distress syndrome in the RESOVIR-1 study and rheumatoid arthritis (RA) with AP1189 in the BEGIN Study. If AP1189 proves to be an efficient and safe drug for treatment of iMN, it could be the first drug specifically approved for this disease and support development of the compound in other diseases associated with proteinuria and NS. Hence, SynAct-CS003 further adds to the prospect of AP1189 and the upside for SynAct and a potential partner or acquirer to take the compound into late-stage clinical development in Phase 2b and 3. Patients would benefit from an add-on to current first line treatment, which does not in all cases lead to control of the disease, as well as alternatives to current second line treatments that are associated with several unwanted and often treatment-limiting side effects. SynAct-CS003 is an exploratory, randomized, double-blind, placebo-controlled study for testing the effect of a once daily dose of 100 mg AP1189 tablets vs placebo for 12 weeks as add-on to treatment with ACE-inhibitors/angiotensin II receptor blocker treatment in iMN patients with severe proteinuria and/or nephrotic syndrome. 12 patients will be treated with 100 mg AP1189 and 6 patients will be treated with placebo. The primary endpoints are to access safety and efficacy measured as change in urinary protein excretion from baseline to end of treatment. Subject To Approve the amendment, SynAct-CS003 will continue at 7 clinical sites in Denmark, Sweden and Norway where the study is already approved by the local Health Authorities and Ethical committees. Tillkännagivande • Jun 30
Synact Pharma Receives pre-IND Response from the U.S. Food and Drug Administration SynAct Pharma AB announced that it was granted and has received written response from the U.S. Food and Drug Administration (FDA) on the request for a Type B pre-IND meeting on the planned development of AP1189 oral tablets for treatment of rheumatoid arthritis in patients with an inadequate response to methotrexate alone (DMARD-IR). Based on the response, the Company will submit an investigational new drug (IND) application according to plan. In response to the background package and questions submitted by SynAct, the FDA'sDivision of Regulatory Operations-Immunology and Inflammation, addressed questions about the study design, clinical development program, and preclinical development, as well as chemistry, manufacturing, and controls (CMC). The response enables SynAct to proceed with the planning and, subject to regulatory approval, execution of Part A of the RESOLVE study, a 4-week dose-response study testing 3 doses of AP1189 vs placebo in a multicenter, double-blind, placebo-controlled study in DMARD-IR patients to be conducted at sites in Europe and USA. Part B of the study is planned as a 12-week study to be conducted in continuation of Part A, with its dose selection based on the outcome of Part A. Tillkännagivande • Jun 21
SynAct Pharma Submits CTA for Clinical Phase 2b Study in RA SynAct Pharma AB announced that it has submitted a Clinical Trial Application (CTA) to initiate the clinical Phase 2b study, EXPAND, with the Company's candidate drug, AP1189, in patients with newly diagnosed rheumatoid arthritis (RA). The EXPAND study is a multicenter, randomized, double-blind, placebo-controlled, 12-week study in newly diagnosed, treatment naïve patients with highly active RA (Clinical Disease Activity Score (CDAI) > 22) who are to start treatment with methotrexate (MTX). EXPAND is a part of SynAct's strategy to further develop AP1189 in RA patients. In the Phase 2a study, BEGIN, 100 mg AP1189 once daily for 4 weeks in combination with MTX treatment was found to be safe and well tolerated and met the primary endpoint of a significantly greater than placebo reduction in clinical disease activity (reduction in CDAI; Placebo: 9.3 points vs 100 mg AP1189: 15.5 points, P<0.05). In addition, treatment with AP1189 was associated with a statistically significant higher proportion of patients achieving 20% improvement in American College of Rheumatology (ACR20) score. (ACR20; Placebo: 33% vs 100 mg AP1189: 61%, P<0.05). In EXPAND, 120 RA patients with high disease activity (CDAI > 22) will be randomized 1:1 for treatment with either the newly developed 100 mg AP1189 tablets or placebo tablets for a once daily dose for 12 weeks, concurrently with the prescribed dosing with MTX. Subject to approval from health authorities, first patient is expected to be enrolled in the study in Third Quarter 2022. The study is expected to benefit from the successful recruitment to the BEGIN study with inclusion of sites in Moldova and Bulgaria. In addition, several secondary efficacy endpoints are defined, including, ACR50, ACR70, CDAI, and Disease activity score 28 (DAS-28) change over time, Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) and Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue), as well as use of corticosteroids as rescue medication. Tertiary endpoints are included to further explore the effect of AP1189 on biomarkers and by evaluation of synovial inflammation using magnetic resonance imaging (MRI). The purpose of the EXPAND study is to confirm the encouraging effects of AP1189 demonstrated in the BEGIN study showing very good safety and a clinically meaningful effect on both primary and secondary efficacy readouts already after four weeks treatment. A major aim is to identify the full treatment potential of the compound, i.e. how large a proportion of patients who respond to the compound. A just as important purpose of the study is to generate safety data during prolonged treatment. Tillkännagivande • May 21
John Haurum Declines Re-Election as Board Member of SynAct Pharma AB SynAct Pharma AB at annual general meeting held on May 20, 2022, the present board member John Haurum hade declined re-election. Tillkännagivande • May 04
SynAct Pharma AB Completes Clinical Pharmacokinetic Test of Ap1189 Tablet SynAct Pharma AB announce that the company's pharmacokinetic study on new tablet formulations of AP1189 has been successfully completed. The data confirms the tablet formulation as superior to, the until now used, AP1189 suspension. Further clinical development of AP1189 will be conducted using the new tablet. The study was setup with three parts. In part 1 of the study, AP1189 formulated as fast release tablets, was tested in 12 healthy volunteers in cross over design with the previously used AP1189 suspension as control. The pharmacokinetic profile of the tablets was similar to that of the suspension with fast absorption and maximal plasma concentration reached within 2 to 3 hours following dosing. The exposure evaluated through area under the curve (AUC) was numerically higher on the tablet whereas the maximum exposure was almost identical between the two formulations. Three out of 12 subjects developed nauseas following dosing with the suspension, whereas no incidents of nausea following dosing with the tablets were reported. In the second part of the study, the tablets were tested in a cross over design in 12 volunteers. On one occasion the tablet was dosed in the fasted state, at the other occasion the tablet was dosed following intake of a high fat diet. Dosing following intake of a high fat diet meal delayed the absorption of the compound meaning that time to maximal exposure was delayed by approximately 2 hours and the maximum concentration in plasma was lower (mean reduction by 33% compared to fasting state), whereas the overall exposure evaluated by AUC was only affected to minor degrees. These results are in line with what would be expected from the compound's physical and chemical characteristics and will not change the current dosing regimen. In the third part of the study, dose linearity in the range of 50 to 300 mg was tested in 12 healthy volunteers. The data showed an almost ideal dose linearity with r2 =0.99. Board Change • Apr 29
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 7 non-independent directors. Director Kerstin Hasselgren was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Dec 02
SynAct Pharma AB Announces Additional Data from the BEGIN Study SynAct Pharma AB announced additional results on the secondary endpoints ACR50 and ACR70 from the Phase 2a study of AP1189 (BEGIN) in early rheumatoid arthritis (RA) patients experiencing severe disease activity. This update includes evaluation of the treatment effects by ACR scoring, named after the American College of Rheumatology. In addition to the ACR20 scores (proportion of the patients that achieved a reduction of ACR score = 20%), the company has analyzed the treatment effects using the ACR50 and ACR70 scores. For ACR50 (=50% improvement in the ACR score) the results for placebo, 50 mg AP1189 and 100 mg AP1189 were 6.7%, 3.5%, and 18.2%, respectively. For ACR70 (=70% improvement in the ACR score) the results were 3.3%, 0% and 9.1% for placebo, 50 mg AP1189 and AP1189 100 mg, respectively. Tillkännagivande • Nov 24
SynAct Pharma AB Reports Positive PK Data on AP1189 Tablets SynAct Pharma AB announced that it has received positive data from the first part of the ongoing pharmacokinetic (PK) study of AP1189 following oral administration of AP1189 tablets to healthy volunteers. Data from a single dose cross-over study in 12 healthy volunteers of dosing of 2 x 50 mg AP1189 Tablets vs 100 mg AP1189 Powder for Suspension (the formulation used in the current clinical phase 2 development program), demonstrates that relevant PK parameters are comparable following dosing tablets and oral suspension. The data supports use of tablets in upcoming clinical studies with AP1189. The data stems from Part 1 of the ongoing PK study SynAct CS004, that will be concluded in first half 2022. Further to the pre-clinical data including repeat dose data in non-rodents filed in the recent priority generating patent application (June 2021), these new human data supports that AP1189 can be administered as an oral tablet inducing fast release and absorption and thereby giving a favorable pharmacokinetic profile supporting once daily dosing. SynAct intends to use the novel AP1189 tablet in the upcoming clinical trials, and thus tablets containing AP1189, and corresponding placebo have already been manufactured and released, and are undergoing regulatory studies to support the extended use of these. Tillkännagivande • Sep 24
SynAct Pharma AB Completes Patient Recruitment to the Phase 2A Begin Study of Ap1189 in Early Severe Rheumatoid Arthritis SynAct Pharma AB announced that patient recruitment to its Phase 2a clinical evaluation of the company's lead candidate compound, AP1189, in early Rheumatoid Arthritis (RA) patients with severe disease activity, the BEGIN study, has been completed. With all patients included into the study, dosing will be concluded in October with the last patient's safety follow-up visit to be conducted in November. SynAct therefore anticipates releasing top-line study data by end of November 2021. SynAct wishes to thank clinical sites, investigators, their staff, and most of all the patients for fully enrolling this trial despite challenges posed by the COVID-19 pandemic. Key results with focus on the primary efficacy readout and safety, from the full data set, will be presented in a press release followed by an investor call when the data is available. The company will continue to update the market on the further progress and the process to finalize the BEGIN study. Tillkännagivande • Aug 27
SynAct Pharma AB Provides an Update on Patient Recruitment in the Phase 2a Clinical Trial of AP1189 in Rheumatoid Arthritis SynAct Pharma AB announced that recruitment in the BEGIN study in Rheumatoid Arthritis (RA) has been extended into the first half of September in order to reach the goal of 105 randomized patients, of which 98 have been recruited to date. As a result of the continued recruitment, reporting of key results previously expected to take place by the end of Third Quarter will be postponed to early Fourth Quarter after which a press release with top-line results will be released immediately. SynAct applauds the efforts of its clinical sites and their patients to keep this important evaluation of AP1189 going strong despite the global challenges on clinical trial recruitment caused by the ongoing pandemic. The BEGIN study is setup as a randomized, placebo-controlled study evaluating two doses of AP1189 (50 and 100 mg given orally once daily) for four weeks against placebo as add-on therapy to methotrexate in patients with severe active rheumatoid arthritis. The primary efficacy endpoint in the study is reduction in disease activity from severe (defined as clinical disease activity >22) to moderate or low disease activity within the four-week treatment period. Interim data based on the evaluation of the first 26 patients demonstrate that 75% of patients treated with 100 mg and 67% of patients treated with 50 mg AP1189 reached the primary readout compared to 44% of the placebo treated patients within 4 weeks of treatment. Tillkännagivande • Aug 26
SynAct Pharma AB Announces Grant of Key European Patent Covering Ap1189 SynAct Pharma AB announced that a European patent was granted covering the company's leading drug candidate AP1189 in methods of treating kidney diseases. SynAct has received information that its European patent EP 3 743 064 B1 was granted on 11 August 2021. The European patent provides exclusivity on the medical use of AP1189 and similar compounds in treating kidney disease, specifically primary nephrotic syndrome, and including membranous nephropathy which is currently being tested in clinical trials. The European patent will now be validated in selected European contracting states. This follows on to the information conveyed in the release by SynAct on 13 April 2021 informing on the `Intention to grant" of a European patent; this European patent has now finally proceeded to grant, as expected. Executive Departure • Aug 04
Chief Medical Officer Thierry Duvauchelle has left the company On the 1st of August, Thierry Duvauchelle's tenure as Chief Medical Officer ended. We don't have any record of a personal shareholding under Thierry's name. Thierry is the only executive to leave the company over the last 12 months. Tillkännagivande • Jun 30
Synact Pharma AB Announces Positive Data from A Phase 2A Trial of Ap1189 in Covid-19 Infected Patients SynAct Pharma AB announced topline results from the Phase 2a clinical trial of AP1189 in Covid-19 infected patients with pulmonary insufficiency. Patients treated with 100mg AP1189 orally once-daily for 2-weeks achieved respiratory recovery (time to normalization of oxygen saturation on ambient air) on average 3.5 days (35%) quicker than placebo treated patients (6.4 days and 9.9 days on average respectively). Data from this exploratory pilot clinical trial supports that AP1189 may help Covid-19 infected patients recover impaired lung function. Patients treated with AP1189 recovered respiratory function on average 3.5 days quicker than did placebo treated patients, a 35% increase in recovery time. Supplemental oxygen requirements decreased at a significant rate in AP1189 treated patients. By day 4, AP1189 treated patients had decreased their average supplemental oxygen requirements by 65% on average compared to a 31% reduction in placebo treated patients (p<0.05, compared with per group baseline oxygen requirements). AP1189 treatment appeared to decrease the rate of progression to ventilator use by 50% with 8.3% (3/36) and 16.7% (3/18) of patients requiring a ventilator in AP1189 and placebo groups respectively. In addition, AP1189 treated patients were on average discharged from the hospital 2.8 days earlier than placebo treated patients. Data from an exploratory assessment indicated AP1189 may have a positive impact on decreasing the incidence of acute kidney injury (AKI patients with 22% of AP1189 patients and 33% of placebo patients demonstrating signs of kidney impairment. Importantly AP1189 was well tolerated and safe with no serious adverse events in the AP1189 group. The study data will be submitted for presentation at an upcoming scientific meeting and/or for publication in an appropriate scientific journal. The aim of the study was to evaluate the safety and efficacy of a two-week, once-daily dosing regimen of AP1189 vs placebo as add-on therapy in patients with Covid-19 induced pulmonary insufficiency. The study, conducted under the RESOVIR collaboration enrolled 54 Covid-19 infected patients at clinical sites at Universidade Federal de Minas, Belo Horizonte, Brazil. The enrolled subjects had pulmonary insufficiency requiring the need for supplemental oxygen. Patients were randomized in a 2:1 ratio to receive AP1189 100 mg once daily for 2 weeks, in addition to standard of care. The primary clinical objective of the study was to explore if AP1189 could speed the time to respiratory recovery (time to normalization of oxygen saturation on ambient air). Tillkännagivande • Jun 24
SynAct Pharma Files Patent Applications Related to AP1189 Derived APIs and Oral Formulations SynAct Pharma AB announced that the company has filed two patent applications covering novel salt and crystal forms related to AP1189 and the oral delivery of AP1189 and these novel forms. These novel forms have beneficial and surprising properties and were discovered as a result of ongoing efforts to both optimize the oral dosing of AP1189 and to further enhance the intellectual property surrounding AP1189. In accordance with the strategy to optimize the oral administration of AP1189, SynAct has also intensified its efforts to develop a formulation of AP1189, taking advantage of the new salt and crystal forms. This furthers the company's stated objective to bring a patient-friendly once-daily oraI dosage form into Phase 2b clinical trials. Tillkännagivande • Jun 01
SynAct Pharma Updates Phase II study with AP1189 SynAct Pharma AB announced that dosing in part 2 of the exploratory clinical Phase 2 study with AP1189 in Covid-19 patients conducted under the RESOVIR collaboration has been completed. The study is a randomized double-blind placebo-controlled study in 54 Covid-19 patients at clinical sites at Universidade Federal de Minas, Belo Horizonte, Brazil. The aim of the study is to evaluate the safety and efficacy of a two-week dosing regimen with AP1189 vs placebo as add-on therapy in patients with Covid-19 induced pulmonary insufficiency, defined as a need for supplementary oxygen to maintain normal saturation. 54 patients have been randomized in a 2:1 ratio to receive AP1189 100 mg or placebo once daily, in addition to standard of care. The primary clinical objective of the study is to show reduction in time to respiratory recovery (i.e. time to normalization of oxygen saturation on ambient air). The RESOVIR collaboration is a scientific and clinical collaboration between Professor Mauro Teixeira, MD, PhD, Universidade Federal de Minas, Belo Horizonte, Brazil, and Professor Mauro Perretti, PhD William Heavy Research Institute, Barts and the London School of Medicine, Queen Mary University, London, UK, and SynAct Pharma AB. 
