Tillkännagivande • Mar 07
Acticor Biotech SAS(ENXTPA:ALACT) dropped from Next Biotech Index Acticor Biotech SAS has been dropped from the Next Biotech Index. Tillkännagivande • Oct 14
Acticor Biotech Announces Chief Financial Officer Changes Acticor Biotech announced the appointment of François Guillet as Chief Financial Officer, replacing Éric Cohen who is leaving to pursue other projects. With over 30 years' experience in financial management, François Guillet will bring to Acticor Biotech his expertise in financial structuring and optimization. His role will be to strengthen the management of the company's finances, while ensuring long-term visibility of Acticor Biotech's global strategy. François Guillet has held positions of great responsibility in companies in a wide variety of sectors, including the high-tech sector, from software publishing at Bea, Oracle and Adobe to the internet, electronics and e-commerce at Monnier Frères. He has contributed to restructuring and turnaround projects in mid-sized companies, with scope extended to Human Resources, Purchasing and Sales Administration. His previous assignments have included managing accounting closures, due diligence and managing multicultural teams internationally, reinforcing his versatility as a financial leader. Tillkännagivande • Oct 11
Acticor Biotech Repositions Glenzocimab in the Treatment of Myocardial Infarction ACTICOR BIOTECH provided an update on its clinical developments evaluating glenzocimab in the treatment of myocardial infarction. LIBERATE: A phase 2b study evaluating glenzocimab in the treatment of myocardial infarction. The LIBERATE phase 2b, randomized and double-blind study will include more than 212 patients suffering from ST-Elevation Myocardial Infarction (STEMI) who are scheduled to undergo percutaneous coronary intervention (PCI). The study’s primary objective is to assess the safety and efficacy of glenzocimab 1,000 mg compared to placebo, in reducing the size of the myocardial infarction 90 days post-event. This study is being conducted in partnership with the University of Birmingham (UK), with clinical experts from the Institute of Cardiovascular Sciences and University Hospitals Birmingham NHS Foundation Trust. The two leading clinical research sites, Queen Elizabeth Hospital in Birmingham and Northern General Hospitalin Sheffield, have been actively recruiting patients since January 2024. To date, 27 patients have been recruited, and study results are expected in Fourth Quarter of 2026. GLORIA: A phase 2 study evaluating glenzocimab in myocardial infarction treatment. A new phase 2 study GLORIA, randomized and double-blind, is being prepared to evaluate glenzocimab in the treatment of myocardial infarction. The study will enroll around 300 patients suffering from STEMI upon emergency admission to cardiac intensive care units. The study’s primary objective is likewise to assess the efficacy of glenzocimab for reducing the surface of myocardial infarct at Day 90 post PCI (Percutaneous Coronary Intervention), as well as safety. The study plans to test several dose levels and optimize the mode of administration to suit the time required for this emergency procedure. The aim of launching this second study, which could be promoted by the Company, is to provide all the clinical and regulatory elements required for a phase 3 registration as early as 2027, while evolving the product's mode of administration to facilitate the next stage of development and, later, adoption by clinicians. Patient recruitment could begin in First Quarter 2025, subject to the Company's financing or the continuation of the project as envisaged in the receivership procedure. Board Change • Sep 17
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 5 non-independent directors. Independent Director Patricia Zilliox was the last independent director to join the board, commencing their role in 2023. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Sep 14
Acticor Biotech SAS, Annual General Meeting, Oct 25, 2024 Acticor Biotech SAS, Annual General Meeting, Oct 25, 2024. Location: 82 avenue du maine, paris France Tillkännagivande • Jul 26
Acticor Biotech Announces the Conclusions of the Interim Futility Analysis in the Green Study Acticor Biotech announced the conclusions of the futility analysis of the phase 2/3 GREEN study evaluating glenzocimab as an adjunct to mechanical thrombectomy in acute ischemic stroke. In the light of the information provided to the members of the Independent Monitoring Committee (IMC), and in accordance with the futility criteria defined in the protocol, the IMC recommends that the GREEN study be discontinued. In light of the Committee's recommendations, sponsor Assistance Publique Hôpitaux de Paris (APHP), in agreement with Professor Mikaël Mazighi, principal investigator of the study, has decided to stop the GREEN study and halt enrolment. To date, 108 patients have been included in the study, the futility analysis only covered the first 78 patients, and all included patients will be analysed after the 90-day protocol follow-up. The GREEN study, sponsored by Assistance Publique - Hôpitaux de Paris, is part of the RHU BOOSTER program, with financial support from the Agence Nationale de la Recherche and the Programme Investissements d'Avenir. GREEN (Glenzocimab for REperfusion in the setting of Endovascular therapy for brain infarctioN) is a randomized, double-blind, multicenter, placebo-controlled Phase 2/3 study of the efficacy and safety of glenzocimab as an adjunct to mechanical thrombectomy in the first 24 hours of acute ischemic stroke. New Risk • Jul 08
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €8.80m (US$9.53m) This is considered a major 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 Share price has been highly volatile over the past 3 months (29% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (€8.80m market cap, or US$9.53m). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (28% increase in shares outstanding). Board Change • May 17
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 3 independent directors. 5 non-independent directors. Independent Director Patricia Zilliox was the last independent director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Tillkännagivande • May 16
Acticor Biotech Announces Presentation of the Main Results of the Phase 2/3 Actisave Study in the Treatment of Stroke at ESOC 2024 Acticor Biotech SAS announced the presentation on May 15, 2024 during the opening session of the 10thEuropean Stroke Organisation Conference (ESOC), of the phase 2/3 study results, ACTISAVE, in the treatment of acute ischemic stroke. During this conference, in the "Hyperacute Management" session on May 15, Dr. Davide Carone from Brainomix Ltd. will also present the latest brain imaging analyses obtained in the ACTIMIS study: "Patients randomized to Glenzocimab suffered less hemorrhagic transformation with greater benefit in larger baseline infarct core," reinforcing the potential of glenzocimab in certain patient subpopulations, particularly those presenting larger volumes of cerebral infarction at baseline. Glenzocimab is also being evaluated in two other clinical studies conducted by academic teams, which do not question their work and confirm their confidence in the potential of the product. Phase 2/3 GREEN study in the treatment of stroke in patients undergoing mechanical thrombectomy with a futility analysis after the inclusion of the first 78 patients (30% of patients) expected in the fourth quarter of 2024; Phase 2b LIBERATE study in the treatment of myocardial infarction with final results expected in the fourth quarter of 2025. The company plans to actively continue discussions with pharmaceutical partners to explore potential strategic collaborations that could support future phases of glenzocimab's development and clinical application. As announced on April 25, 2024, during the release of the ACTISAVE results, the company is able to fund its operations until October 2024. The European Stroke Organisation (ESO) is a pan-European society of researchers and physicians specializing in strokes, national and regional stroke societies, and non-professional organizations, founded in December 2007. ESO is a non-governmental organization composed of individual and organizational members. ESO serves as the voice of stroke in Europe, harmonizing stroke care across Europe and taking action to reduce the burden of stroke at regional and global levels. Tillkännagivande • Apr 26
Acticor Biotech SAS Announces Topline Results of ACTISAVE Phase 2/3 Study in Stroke Treatment Acticor Biotech SAS announced the first results of its ACTISAVE phase 2/3 study in the treatment of acute ischemic stroke. Analysis of the first results shows no evidence of efficacy for either the primary endpoint, the proportion of patients with severe disability or death (mRS 4-6) at 90 days after the stroke, or for the secondary endpoint, the proportion of patients with no disability (mRS 0-2) at 90 days. As a reminder, ACTISAVE (NCT05070260), an international, adaptive, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 study, evaluated the safety and efficacy of a single dose of glenzocimab used in combination with the standard of care (thrombolysis +/- thrombectomy) for acute ischemic stroke. The study was deployed in the United States, Europe (8 countries), Israel and the United Kingdom. Glenzocimab is currently evaluated in two other clinical studies sponsored by academic teams: A Phase 2/3 GREEN study in stroke patients undergoing mechanical thrombectomy, with a futility analysis following the inclusion of the first 78 patients (30% of patients) expected in Fourth Quarter 2024. A phase 2b LIBERATE study in the treatment of myocardial infarction, with final results expected in Fourth Quarter 2025. Tillkännagivande • Apr 15
Acticor Biotech Will Present the Clinical Results of Its Phase 2/3 Actisave Study in the Treatment of Stroke At Esoc 2024 Acticor Biotech SAS announces its participation in the European Stroke Organization Conference (ESOC) 2024, to be held from 15 to 17 May 2024 in Basel, Switzerland. ESOC is the leading European forum for stroke research and the preferred platform for the publication of major clinical trial data. As a reminder, ACTISAVE (NCT05070260) is an international, adaptive, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 study evaluating the safety and efficacy of a single dose of glenzocimab used in combination with the standard of care (thrombolysis +/- thrombectomy) for acute ischemic stroke. Deployed in the United States, Europe, Israel, and United Kingdom, ACTISAVE has enrolled 438 patients, of whom about 40% have undergone mechanical thrombectomy. Board Change • Mar 18
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 3 independent directors. 5 non-independent directors. Independent Director Patricia Zilliox was the last independent director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Tillkännagivande • Mar 16
Acticor Biotech SAS has completed a Follow-on Equity Offering in the amount of €8.031849 million. Acticor Biotech SAS has completed a Follow-on Equity Offering in the amount of €8.031849 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 2,261,260
Price\Range: €3.13
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 304,826
Price\Range: €3.13
Transaction Features: Reserved Share Offering Tillkännagivande • Mar 15
Acticor Biotech SAS has filed a Follow-on Equity Offering in the amount of €7 million. Acticor Biotech SAS has filed a Follow-on Equity Offering in the amount of €7 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 2,236,422
Price\Range: €3.13
Transaction Features: Reserved Share Offering Tillkännagivande • Feb 08
The University of Birmingham and Acticor Biotech Announce the First Patient Treated in LIBERATE, First Clinical Trial Evaluating Glenzocimab for Heart Attack The University of Birmingham and Acticor Biotech announced the first patient treated in the LIBERATE clinical study to evaluate glenzocimab efficacy in myocardial infarction. In 2022, the University of Birmingham and Actic or Biotech signed a partnership agreement to evaluate glenzocim AB efficacy in myocardial infARction in a new clinical trial called LIBERATE. Having obtained full regulatory approval in August 2023, two cutting-edge clinical research sites, namely the Queen Elizabeth Hospital in Birmingham and the Northern General Hospital in Sheffield, are involved in the study. The primary objective of the study is to evaluate both the safety and efficacy of glenzocimab at a dosage of 1000 mg compared to a placebo, specifically focusing on the reduction of myocardial infarct size at Day 90 post-treatment. Dr. Mark Thomas, Associate Professor of Cardiology at the University of Birmingham and Honorary Consultant Cardiologist and Director of the Cardiovascular Research Unit at Northern General Hospital, said: "We are very happy to have started recruit into the LIBERATE clinical trial. This is the first time worldwide that this class of medication has been investigated in patients with heart attacks, after showing great promise in patients with stroke. The company are very pleased to now recruit patients in the LIBERATE clinical trial". Tillkännagivande • Jan 26
Acticor Biotech SAS to Report Fiscal Year 2023 Results on Apr 30, 2024 Acticor Biotech SAS announced that they will report fiscal year 2023 results on Apr 30, 2024 Tillkännagivande • Jan 23
Acticor Biotech Announces Publication of ACTIMIS Clinical Study Results in the Lancet Neurology Journal ACTICOR BIOTECH announced the publication of phase 1b/2a clinical results of ACTIMIS study in The Lancet Neurology Journal. The manuscript is entitled: Safety and efficacy of platelet glycoprotein VI inhibition in acute ischaemic stroke (ACTIMIS): a phase 1b/2a randomized, placebo-controlled, trial. The ACTIMIS clinical trial evaluated glenzocimab in combination with the reference treatment (thrombolysis with or without thrombectomy) in patients presenting with an Acute Ischemic Stroke. This publication displays the full analysis of ACTIMIS results. The key results presented in the manuscript are: Achievement of ACTIMIS primary endpoint, confirming the safety of glenzocimab in AIS patients; In phase 2a, glenzocimab 1000 mg, as add-on therapy to alteplase, was associated with reduced symptomatic intracerebral haemorrhage (0% vs 10%) and all-cause mortality (8% vs 21%) compared with placebo; Patients with the most severe strokes and at highest risk of intracranial haemorrhage might be the best responders in this study. The results of ACTIMIS were first presented during the European Stroke Organisation Conference (ESOC) in 2022. Find here previous exchanges with Professor Mikael Mazighi MD, PhD who is the global study coordinator: The media presentation: As a reminder, the ongoing phase 2/3 clinical trial ACTISAVE has completed its recruitment in October 2023 with expected results in the second quarter of 2024. Tillkännagivande • Nov 29
Acticor Biotech SAS has filed a Follow-on Equity Offering in the amount of €2.55108 million. Acticor Biotech SAS has filed a Follow-on Equity Offering in the amount of €2.55108 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 850,360
Price\Range: €3 Breakeven Date Change • Nov 29
Forecast to breakeven in 2025 The analyst covering Acticor Biotech SAS expects the company to break even for the first time. New forecast suggests the company will make a profit of €16.4m in 2025. Average annual earnings growth of 82% is required to achieve expected profit on schedule. Tillkännagivande • Nov 10
ACTICOR BIOTECH Announces Timely Completed Patient Recruitment of Its Phase 2/3 Study in Stroke ACTICOR BIOTECH announced the timely completion of enrollment in the ACTISAVE Phase 2/3 clinical trial in patients with acute ischemic stroke (AIS). ACTISAVE (NCT05070260) is an international, adaptive, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 study evaluating the safety and efficacy of a single dose of glenzocimab used in combination with the standard of care (thrombolysis +/- thrombectomy) for acute ischemic stroke. Deployed in the United States, Europe, Israel, and United Kingdom, ACTISAVE has enrolled 438 patients, of whom about 40% have undergone mechanical thrombectomy. As a reminder, following consultations with the European (EMA) and American (FDA) regulatory agencies, and in agreement with ACTISAVE Scientific Committee, Acticor Biotech decided in September 2023 to change the main endpoint of the study by retaining only one single endpoint, namely the reduction in the number of patients whoied or suffered from severe disability as a result of AIS (mRS score 4-6 at 90 days). As previously announced, phase 2/3 clinical results are expected in the second quarter of 2024. Based on these results and the recommendations of international experts in stroke, Acticor Biotech plans to consult again with the EMA and the FDA in 2024 to confirm that the Phase 3 design will support final registration in both Europe and the United States, envisaged by 2028 at the latest. New Risk • Oct 06
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 6.3% 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 Negative equity (-€2.2m). Earnings are forecast to decline by an average of 23% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€21m net loss in 3 years). Share price has been volatile over the past 3 months (6.3% average weekly change). Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (€52.9m market cap, or US$56.0m). Tillkännagivande • Sep 08
Acticor Biotech and University of Birmingham Announces The UK Regulatory Agency (MHRA) Approves the Protocol of LIBERATE Study, the First Clinical Trial Evaluating Glenzocimab for Heart Attacks On September 7th, 2023, the University of Birmingham and Acticor Biotech announced the full regulatory approval of LIBERATE clinical study. In 2021, the University of Birmingham and Acticor Biotech signed a partnership agreement to evaluate glenzocimab efficacy in myocardial infarction in a new clinical trial called LIBERATE. The University has received full regulatory approvals to initiate the study. This new clinical trial is based on a long-standing collaboration between Acticor Biotech and the University of Birmingham. The publication in August of a scientific paper from Dr Mark Thomas entitled: “Amplified inhibition of atherosclerotic plaque-induced platelet activation by glenzocimab with dual antiplatelet therapy “ (link to the publication) in the Journal of Thrombosis and Haemostasis, reinforced the mode of action of glenzocimab and its major role as an antithrombotic drug. The randomised, double-blind Phase 2b LIBERATE study will recruit more than 200 patients suffering from a ST-elevation myocardial infarction (STEMI) and planned for a percutaneous coronary intervention. The study aims to assess the safety and the efficacy of glenzocimab 1000 mg versus placebo to reduce the myocardial infarct size at Day 90 post-treatment. The trial will be conducted in two acute care hospitals in the UK: the Queen Elizabeth Hospital, Birmingham and the Northern General Hospital, Sheffield. Patient recruitment is expected to start by the end of 2023. Breakeven Date Change • Jul 26
Forecast to breakeven in 2023 The analyst covering Acticor Biotech SAS expects the company to break even for the first time. New forecast suggests the company will make a profit of €924.9k in 2023. Board Change • Jul 26
Less than half of directors are independent There are 6 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 3 independent directors. 5 non-independent directors. Independent Director Patricia Zilliox was the last independent director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. 