Workflow
masitinib
icon
Search documents
AB Science today reports its revenues for the first half of 2025 and provides an update on its activities
Globenewswire· 2025-10-10 16:10
PRESS RELEASE AB SCIENCE PRESENTS ITS FINANCIAL RESULTS FOR THE FIRST HALF OF 2025 AND KEY EVENTS DURING THE PERIOD Financial and corporate situation Operating deficit reduced by 24% compared to the first half of 2024, amounting to €2.7 million as of June 30, 2025Capital increase through private placements for a total amount of €6.3 million Clinical development Masitinib platform: Authorization from several European countries for the confirmatory Phase 3 study with masitinib in amyotrophic lateral sclerosi ...
AB Science announces a slight delay in the publication of its 2025 half-year financial report
Globenewswire· 2025-09-30 16:32
Core Viewpoint - AB Science has announced a slight delay in the publication of its half-year financial report for 2025, which is now scheduled for October 10, 2025, to allow auditors to complete their work [1][2]. Company Overview - AB Science, founded in 2001, is a pharmaceutical company focused on the research, development, and commercialization of protein kinase inhibitors (PKIs), targeting diseases with high unmet medical needs [3]. - The company has developed a proprietary portfolio of molecules, with its lead compound, masitinib, registered for veterinary medicine and under development for human medicine in various fields including oncology and neurological diseases [4].
AB Science announces the successful completion of a 2.55 million euros private placement
Globenewswire· 2025-08-04 05:58
Core Points - AB Science S.A. successfully completed a private placement raising a total gross amount of EUR 2.55 million from a limited number of investors [1][3][4] Use of Proceeds - The net proceeds from the private placement will be used to finance ongoing activities, particularly focusing on the clinical development of the AB8939 program [3] Private Placement Details - The private placement involved the issuance of 2,276,787 new ordinary shares, each with one share warrant attached, without preferential subscription rights [4][5] - The issue price of one ABSA is EUR 1.12, representing a 24.68% discount to the volume-weighted average price over the three trading days preceding the price setting [6][7] Share Capital Impact - Following the issuance, the company's total share capital will be EUR 704,695.95, consisting of 63,706,916 ordinary shares, which could increase to 65,983,703 shares if all warrants are exercised [11][12] Trading and Admission - The new shares are expected to be admitted to trading on Euronext Paris on August 7, 2025, and will be assimilated to existing shares [15] About AB Science - AB Science specializes in the research, development, and commercialization of protein kinase inhibitors, targeting diseases with high unmet medical needs [24]
AB Science has received approval from several European countries to initiate the confirmatory phase 3 study of masitinib in ALS
Globenewswire· 2025-07-24 05:57
Core Viewpoint - AB Science has received approval from several European countries to initiate a confirmatory Phase 3 study of masitinib in amyotrophic lateral sclerosis (ALS), following validation by the EMA and FDA [1][2]. Group 1: Study Design and Population - The confirmatory Phase 3 study, AB23005, is a multicenter, randomized, double-blind, placebo-controlled trial designed to confirm the efficacy and safety of masitinib in ALS patients [3]. - The study will enroll 408 patients with ALS, focusing on those with normal disease progression and no total loss of function [4]. - The optimal population for the study is defined as patients before complete loss of function, representing approximately 75% of the total ALS patient population [5][6]. Group 2: Clinical Data and Mechanism of Action - Previous studies, including the Phase 2B/3 study AB10015, indicated a median survival increase of +12 months for the targeted patient population [5]. - Masitinib's mechanism of action involves targeting mast cells and microglia, which has been supported by preclinical studies demonstrating its immunomodulatory properties [11][22]. Group 3: Statistical Considerations - The AB23005 study aims to enroll approximately 200 patients per treatment group, more than double the number in the previous study, to enhance statistical power [10]. - The optimal population included approximately 90 patients per treatment group in the AB10015 study, where masitinib showed statistically significant effects on key endpoints [9]. Group 4: Intellectual Property and Regulatory Status - AB Science has secured patent protection for masitinib in ALS until 2037, with potential extensions in certain jurisdictions [14][15]. - Masitinib has received orphan drug designation from both the EMA and FDA, granting it marketing exclusivity for 10 years in Europe and 7 years in the United States [17].
AB Science announces the successful completion of a EUR 1.925 million private placement
Globenewswire· 2025-07-08 06:02
Core Viewpoint - AB Science S.A. successfully completed a private placement raising EUR 1.925 million to finance ongoing activities, particularly the clinical development of the AB8939 program [1][3]. Use of Proceeds - The net proceeds from the private placement will be utilized to support the clinical development of the AB8939 program and strengthen the company's cash position to meet financing needs for 2025 and beyond [3]. Private Placement Details - The private placement involved the issuance of 1,645,302 new ordinary shares, each with an attached share warrant (BSA), without preferential subscription rights [4][5]. - The issue price of one ABSA is EUR 1.17, reflecting a 24.36% discount to the volume-weighted average price (VWAP) of AB Science shares over the three trading days prior to the pricing [6][7]. Shareholder Impact - Post-placement, the new shares will represent approximately 2.47% of the company's share capital on a non-diluted basis before the placement and 2.41% after [5]. - Existing shareholders who do not participate in the private placement will experience a dilution of their shareholding [12][22]. Trading and Admission - The new shares are expected to be admitted to trading on Euronext Paris on July 10, 2025, and will be assimilated to existing shares [13]. Lock-up Commitments - The company has agreed to a 45-day lock-up period for the investors and a 90-day lock-up for its directors and officers following the settlement and delivery of the private placement [17].
AB Science: Masitinib receives FDA and EMA authorization for confirmatory phase 3 trial in metastatic castrate-resistant prostate cancer
Globenewswire· 2025-07-04 06:01
Core Viewpoint - The FDA and EMA have authorized a confirmatory Phase 3 trial for masitinib in metastatic castrate-resistant prostate cancer (mCRPC), utilizing a biomarker-driven patient selection approach to target those most likely to benefit from the treatment [1][2]. Study Design - Study AB22007 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial designed to confirm the efficacy and safety of masitinib in combination with docetaxel for mCRPC patients [3]. - The trial will enroll 600 patients, with a primary endpoint of radiographic progression-free survival (rPFS) and overall survival as the first secondary endpoint [4]. Medical Need - Masitinib is positioned to address a high unmet medical need in mCRPC patients who have relapsed after hormone treatments, as there are currently no registered drugs for use in combination with docetaxel in this patient population [5][6]. - Metastatic prostate cancer has a 5-year survival rate of approximately 30%, highlighting the critical need for effective treatments [7]. Patient Population - The estimated population of mCRPC patients eligible for chemotherapy is around 75,000 in the EU and 50,000 in the USA [8]. - The biomarker alkaline phosphatase (ALP) has been validated to predict the response to masitinib in mCRPC patients, indicating a potential new first-line treatment option [8]. Efficacy Results - The combination of masitinib and docetaxel showed a significant progression-free survival (PFS) benefit, with a hazard ratio of 0.79, indicating a 21% reduction in the risk of progression compared to control [10]. - A greater treatment effect was observed in patients with lower baseline ALP levels, with a 47% reduced risk of progression in those with ALP ≤ 100 IU/L [11]. Safety Profile - The safety profile of masitinib in combination with docetaxel was acceptable, with no new safety signals observed, marking a successful example of a Phase 3 trial that improved PFS [13]. Patent Protection - AB Science has filed a patent application for methods of treating mCRPC with masitinib, which has been granted by the European Patent Office, providing protection until 2042 for the treatment of mCRPC in patients with low metastatic involvement [14][15].
AB Science provides an update on the renegotiation of loan repayment terms with its financial creditors
Globenewswire· 2025-06-30 06:03
Core Viewpoint - AB Science has reached an agreement in principle with its financial creditors to postpone the repayment of its bank debt by 24 months, contingent upon the postponement of a loan repayment with the EIB by at least 12 months [2][7]. Group 1: Loan Repayment Terms - The total amount of bank debt to be postponed is approximately 3.7 million euros, with the agreement conditional on a 12-month delay for a 12 million euro loan from the EIB, originally due in January and December 2028 [2][4]. - The restructuring terms include state-guaranteed loans (PGE) with a balance of 3.5 million euros [3]. - A freeze on principal repayments is set from January 1, 2025, to December 31, 2026, with amortization resuming on January 1, 2027 [8]. Group 2: Financial Strategy - Savings from the postponed repayments will be invested in research and development [7]. - The EIB loan is structured in two tranches of 6 million euros each, with specific maturity dates in 2028 [4]. - An innovation loan with a balance of 0.2 million euros will also have a freeze on principal repayments from January 1, 2025, to September 30, 2025, with amortization resuming on October 1, 2025 [8]. Group 3: Company Overview - AB Science, founded in 2001, specializes in the research, development, and commercialization of protein kinase inhibitors (PKIs) targeting diseases with high unmet medical needs [5][6]. - The company's lead compound, masitinib, is already registered for veterinary use and is being developed for human medicine across various disease areas [6].
AB Science - New peer-reviewed data provide strong evidence supporting masitinib potential for the treatment of Alzheimer’s disease
Globenewswire· 2025-06-23 06:03
Core Viewpoint - New peer-reviewed data supports masitinib's potential as a treatment for sporadic Alzheimer's disease through cognitive enhancement and neuroprotection [1][5][6] Group 1: Clinical Evidence - A new study from independent researchers indicates that masitinib improves cognitive functions in a mouse model of sporadic Alzheimer's disease, showing enhancements in memory, learning, and anxiety-like behaviors [3][4] - The study demonstrated that masitinib reduced toxic brain proteins, alleviated synaptic dysfunction, and suppressed microglial activation, which is linked to inflammation in Alzheimer's disease [4][5] - Results from a phase 2B/3 study (AB09004) showed that masitinib treatment significantly reduced cognitive impairment in patients with mild Alzheimer's disease, with a notable improvement in the mild impairment subgroup [8][9] Group 2: Regulatory and Development Status - The FDA and key EU countries have authorized a phase 3 clinical study (AB21004) to evaluate masitinib as a disease-modifying therapy for Alzheimer's disease [10][11] - The phase 3 study aims to confirm previous findings from the phase 2B/3 study regarding masitinib's efficacy in slowing cognitive deterioration and improving daily living activities [12] Group 3: Intellectual Property - AB Science has filed a patent application for masitinib's use in treating Alzheimer's disease, which, if granted, will provide protection until 2041 [13]
AB Science announces the settlement delivery of its latest capital increase for €1.8 million
Globenewswire· 2025-05-23 05:52
Company Overview - AB Science S.A. is a pharmaceutical company founded in 2001, specializing in the research, development, and commercialization of protein kinase inhibitors (PKIs) [5] - The company is headquartered in Paris, France, and is listed on Euronext Paris under the ticker AB [5] - AB Science focuses on diseases with high unmet medical needs, including oncology, neurological diseases, inflammatory diseases, and viral diseases [5] Recent Capital Increase - AB Science announced a capital increase of €1.8 million, which was settled and delivered on May 23, 2025 [1] - This capital increase was subscribed by a limited number of investors and is expected to strengthen the company's cash position [2] Product Development - Masitinib is a novel oral tyrosine kinase inhibitor being developed to target mast cells and macrophages, with potential applications in oncology, inflammatory diseases, and central nervous system diseases [3] - AB8939 is a new synthetic microtubule-destabilizing drug candidate that shows broad anticancer activity and may overcome drug resistance associated with standard chemotherapies [4]
AB Science announces the successful completion of a EUR 1.8 million private placement
Globenewswire· 2025-05-20 05:49
Core Viewpoint - AB Science S.A. successfully completed a private placement raising EUR 1.8 million to finance ongoing activities, particularly focusing on the clinical development of the AB8939 program [1][3]. Group 1: Private Placement Details - The private placement involved the issuance of 1,538,463 new ordinary shares, each with one share warrant attached, without preferential subscription rights [4]. - The issue price of one ABSA was set at EUR 1.17, reflecting a 24.8% discount to the volume-weighted average price over the three trading days prior [6][7]. - The total share capital post-placement will be EUR 661,764.30, comprising 59,368,757 ordinary shares, with potential increases if all BSAs are exercised [11]. Group 2: Use of Proceeds - The net proceeds from the private placement will primarily be allocated to the clinical development of the AB8939 program [3]. Group 3: Shareholder Impact - The issuance of ABSAs will result in a dilution of existing shareholders' stakes, with specific percentages outlined for major shareholders before and after the placement [12][14]. - The theoretical value of each BSA is estimated at EUR 0.4053, based on a volatility of 34.355% [9]. Group 4: Trading and Listing - The new shares are expected to be admitted to trading on Euronext Paris on May 22, 2025, and will be assimilated to existing shares [16]. - The BSAs are anticipated to be listed on Euronext Growth Paris by May 26, 2025 [10]. Group 5: Company Overview - AB Science specializes in the research, development, and commercialization of protein kinase inhibitors, targeting diseases with high unmet medical needs [25]. - The lead compound, masitinib, is being developed for various medical applications, including oncology and inflammatory diseases [25][23].