Aankondiging • 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 01
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 Swedish stocks, typically moving 9.1% 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 (9.1% average weekly change). Market cap is less than US$100m (kr845.6m market cap, or US$90.9m). New Risk • May 27
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 (kr892.7m market cap, or US$96.1m). New Risk • May 05
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: kr896.0m (US$96.7m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr896.0m market cap, or US$96.7m). Breakeven Date Change • Feb 18
No longer forecast to breakeven The analyst covering SynAct Pharma no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of kr183.1m in 2026. New forecast suggests the company will make a loss of kr28.2m in 2027. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Recent Insider Transactions • Dec 25
Chairman of Board recently bought kr72k worth of stock On the 19th of December, Anders Kronborg bought around 3k shares on-market at roughly kr20.84 per share. This transaction amounted to 5.4% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Anders' only on-market trade for the last 12 months. Aankondiging • Dec 12
SynAct Pharma AB, Annual General Meeting, Jun 11, 2026 SynAct Pharma AB, Annual General Meeting, Jun 11, 2026. New Risk • Oct 31
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: kr91m Forecast net loss in 1 year: kr82m 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 (-kr89m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (kr82m net loss next year). Shareholders have been diluted in the past year (29% increase in shares outstanding). Aankondiging • 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. Breakeven Date Change • Aug 20 The analyst covering SynAct Pharma previously expected the company to break even in 2026. New forecast suggests the company will make a profit of kr183.1m in 2026. Average annual earnings growth of 59% is required to achieve expected profit on schedule.
New Risk • Aug 19
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: kr953.4m (US$99.4m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-kr107m free cash flow). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Market cap is less than US$100m (kr953.4m market cap, or US$99.4m). Price Target Changed • Jun 27
Price target increased by 14% to kr25.00 Up from kr22.00, the current price target is provided by 1 analyst. New target price is 34% above last closing price of kr18.70. Stock is up 161% over the past year. The company posted a net loss per share of kr2.08 last year. 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: -kr107m 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 (-kr107m free cash flow). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (kr756.7m market cap, or US$78.8m). Aankondiging • 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. Aankondiging • 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). Aankondiging • 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. Aankondiging • 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. New Risk • Feb 19
New major risk - Revenue and earnings growth Earnings have declined by 37% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 37% per year over the past 5 years. Shareholders have been substantially diluted in the past year (38% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (kr73m net loss next year). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (kr864.5m market cap, or US$80.4m). New Risk • Jan 17
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 37% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Shareholders have been substantially diluted in the past year (37% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr501.5m market cap, or US$45.0m). Aankondiging • 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 New Risk • Jan 07
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swedish stocks, typically moving 12% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (kr437.7m market cap, or US$39.5m). Aankondiging • Nov 29
SynAct Pharma AB, Annual General Meeting, May 29, 2025 SynAct Pharma AB, Annual General Meeting, May 29, 2025. Aankondiging • 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. Aankondiging • 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 Aankondiging • 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 31
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 Swedish stocks, typically moving 8.8% 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 (-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 (8.8% average weekly change). Shareholders have been diluted in the past year (30% increase in shares outstanding). Market cap is less than US$100m (kr364.6m market cap, or US$35.5m). Aankondiging • 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 kr1.9m worth of stock On the 8th of May, Thomas Boesen bought around 19k shares on-market at roughly kr101 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 kr1.9m worth in shares. Aankondiging • 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 New Risk • Apr 01
New major risk - Revenue and earnings growth Earnings have declined by 47% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings have declined by 47% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (12% increase in shares outstanding). Market cap is less than US$100m (kr307.3m market cap, or US$28.7m). Recent Insider Transactions • Mar 28
Chief Operating Officer recently sold kr145k worth of stock On the 21st of March, Thomas Boesen sold around 21k shares on-market at roughly kr6.90 per share. This transaction amounted to 100% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Despite the recent sale, Thomas has been a net buyer over the last 12 months, purchasing a net total of kr31k worth of shares. Aankondiging • 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 Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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 (19% 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 (kr295.6m market cap, or US$28.6m). Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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 Aankondiging • 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. Aankondiging • 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). Aankondiging • 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). Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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). Recent Insider Transactions • Jun 21
Chief Operating Officer recently bought kr78k worth of stock On the 16th of June, Thomas Boesen bought around 1k shares on-market at roughly kr74.34 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Despite this recent buy, Thomas has been a net seller over the last 12 months, reducing personal holdings by kr3.4m. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Recent Insider Transactions • Dec 16
Chief Operating Officer recently sold kr3.4m worth of stock On the 12th of December, Thomas Boesen sold around 43k shares on-market at roughly kr80.66 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. Board Change • Nov 16
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. Aankondiging • Oct 22
SynAct Pharma AB, Annual General Meeting, May 25, 2023 SynAct Pharma AB, Annual General Meeting, May 25, 2023. Board Change • Apr 27
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. 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. Aankondiging • May 04
Synact Pharma Expands Ap1189 Begin Study in Rheumatoid Arthritis Uk Version SynAct Pharma AB announced that based upon the encouraging results seen in part 1 of the phase 2 clinical study BEGIN of AP1189, the company has decided to increase the study size in an effort to demonstrate statistical significance in the trial. Topline data from part 1 of the BEGIN study with AP1189 in early rheumatoid arthristis (RA) demonstrated a 66-74% treatment effect for the 50mg and 100mg dose groups respectively (Part 1 primary endpoint attainment of: placebo - 44%, 50mg - 67% and 100mg - 75%, previously reported in November 2020). Reporting of the key data is planned to take place in Third Quarter of this year and the company also plans to submit the study results for presentation at the American College of Rheumatology´s annual meeting in San Francisco in November 2021. This timing is of course dependent upon external conditions such as the ongoing COVID-19 pandemic but is based upon current recruitment rates and the anticipated performance of additional study sites as well as the reopening of study sites closed due to the pandemic. Aankondiging • Mar 19
SynAct Pharma AB Initiates Dosing in Part 2 of the Clinical Phase II Study with AP1189 in Covid-19 Infected Patients UK Version SynAct Pharma AB announced that dosing in the second part of the exploratory clinical Phase 2 study with AP1189 in Covid-19 patients conducted under the RESOVIR collaboration has been initiated following completion of the initial open label part of study. The second part is a randomized double-blind placebo-controlled study in 56 Covid-19 patients at clinical sites at Universidade Federal de Minas, Belo Horizonte, Brazil. The initial open label part of the study was conducted in 6 patients referred to hospital with Covid-19 induced pulmonary insufficiency, defined as a need for supplementary oxygen to maintain normal saturation. The patients, 4 women and 2 men aged between 38 and 59, all had SaPO2 lower than 93% on spontaneous respiration, and all 6 patients were treated with oxygen on nasal catheter with flow between 2-5 LO2/min. The patients were treated with once daily oral dosing of 100 mg AP1189 as add-on to standard therapy. The compound was found to be safe and well tolerated, and the patients were discharged between day 3 and 9 of treatment as none of them developed a need for more intensive pulmonary support. As no safety concerns have been identified, recruitment to part 2 of the study has been initiated. As of March 16, 2021, 16 patients had been included to the second part of the study. The second part of the study is set up to evaluate the safety and efficacy of a two-weeks 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. Up to 54 patients will be 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 top line results for the study are expected in second quarter of 2021. 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. Recent Insider Transactions • Mar 04
Chief Financial Officer recently sold kr2.9m worth of stock On the 26th of February, Henrik Stage sold around 57k shares on-market at roughly kr51.48 per share. This was the largest sale by an insider in the last 3 months. This was Henrik's only on-market trade for the last 12 months. Aankondiging • Feb 11
SynAct Pharma AB Names James Knight as Chief Business Officer SynAct Pharma AB (SynAct) announced the appointment of James Knight as Chief Business Officer (CBO). He will head up business development and pipeline portfolio management and has more than 25 years of experience in the biopharmaceutical industry. Mr. Knight brings highly relevant experience and skills to the SynAct team as it advances its lead selective melanocortin asset AP1189 through Phase 2a clinical proof of concept trials. James was formally the VP of Portfolio Strategy at Questcor Pharmaceuticals where he was responsible for leading the expansion of Acthar Gel from two promoted indications in two specialty audiences to nine promoted indications in five specialty areas including rheumatology. James is also serving as the CBO of TXP Pharma, an early-stage Swiss biotech company that is developing locally administered, injectable melanocortin agonists. Most recently James was the Senior Vice President, Head of Corporate Development of California-based BioTime Inc. where he drove R&D rationalization and corporate development efforts that culminated with the acquisition of Asterias Biotherapeutics and the repositioning of BioTime as a cellular therapeutics company. 
