Core Viewpoint - AB Science has published a new article identifying AB8939 as a promising drug candidate for treating refractory acute myeloid leukemia (AML) and potentially other cancers, highlighting its dual mechanism of action and effectiveness against multidrug resistance [1][2]. Group 1: Drug Candidate Characteristics - AB8939 is characterized as a novel synthetic microtubule destabilizer and ALDH inhibitor, showing potential for treating high-risk AML, particularly in cases with complex karyotypes, MECOM rearrangements, and TP53 mutations [3][4]. - The drug exhibits dual action against proliferating tumor cells through tubulin disruption and quiescent, resistant stem cells via ALDH inhibition, making it a unique therapeutic agent [3][4]. Group 2: Mechanism of Action - AB8939 acts as a microtubule-targeting agent by binding to the colchicine-binding site on β-tubulin, disrupting the microtubule network, leading to cell cycle arrest in the G2/M phase and subsequent apoptosis [4]. - It is a potent inhibitor of ALDH1 and ALDH2 enzymes, which are often overexpressed in tumors and associated with cancer stem cells, tumor progression, and resistance to therapy [4]. Group 3: Efficacy and Resistance - AB8939 demonstrates strong antiproliferative activity against various human cancer cell lines, particularly hematopoietic cancers, with IC₅₀ values in the nanomolar range [4]. - The drug can overcome major mechanisms of drug resistance, including P-glycoprotein (P-gp) efflux and high β3-tubulin expression, retaining efficacy in resistant AML patient blasts [4][5]. Group 4: Clinical Trials - AB8939 is currently being evaluated in a Phase I/II clinical trial (AB18001) for patients with refractory and relapsed AML, with regulatory approval received to initiate the third stage of the study [5][6]. - The first two stages of the trial involved 28 and 13 patients, respectively, determining the maximum tolerated dose (MTD) of 21.3 mg/m² after both three and fourteen consecutive days of treatment [6]. Group 5: Intellectual Property and Regulatory Status - AB8939 is protected by intellectual property rights until 2036 or even 2044, with a patent covering its composition and use in AML treatment granted in multiple countries [7][8][9]. - The drug has received orphan drug designation from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), granting it marketing exclusivity for 10 years in Europe and 7 years in the US [10].

Core Viewpoint - AB Science has announced the identification and characterization of a novel small synthetic molecule, AB8939, as a promising drug candidate for treating refractory acute myeloid leukemia (AML) and potentially other cancers [1] Group 1: Drug Candidate Characteristics - AB8939 is identified as a powerful compound with a dual mechanism of action, disrupting microtubule formation and inhibiting ALDH enzymes, which are linked to therapy resistance and the survival of leukemic stem cells [2][3] - The drug shows potential for treating high-risk AML cases, particularly those with complex karyotypes, MECOM rearrangements, and TP53 mutations [3] - AB8939 has demonstrated strong antiproliferative activity against various human cancer cell lines, especially hematopoietic cancers, with IC₅₀ values in the nanomolar range [4] Group 2: Mechanism of Action - AB8939 acts as a microtubule destabilizer by binding to the colchicine-binding site on β-tubulin, leading to cell cycle arrest and apoptosis [4] - It also inhibits ALDH1 and ALDH2, which are often overexpressed in tumors and associated with cancer stem cells and therapy resistance [4] - The drug can overcome major mechanisms of drug resistance, such as P-glycoprotein (P-gp) efflux and high β3-tubulin expression, allowing it to remain effective in resistant cancer cells [4] Group 3: Clinical Trials - AB8939 is currently being evaluated in a Phase I/II clinical trial (AB18001) for patients with refractory and relapsed AML, with regulatory approval received to initiate the third stage of the study [5][6] - The first two stages of the trial involved 28 and 13 patients, respectively, determining the maximum tolerated dose (MTD) of 21.3 mg/m² after both three and fourteen consecutive days of treatment [6] Group 4: Intellectual Property and Regulatory Status - AB Science retains full ownership of the intellectual property rights for AB8939, with protection extending until 2036 or even 2044 for specific uses [7][9] - The drug has received orphan drug designation from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), granting marketing exclusivity for 10 years in Europe and 7 years in the US [10] Group 5: Preclinical Evidence - In preclinical models, AB8939 has shown significant inhibition of tumor growth and increased survival rates in Ara-C-resistant AML mouse models [12] - The drug effectively eradicated leukemic stem cells in patient-derived xenograft models, suggesting its potential to reduce the risk of disease relapse [12]

Core Insights - AB Science announced a new publication on MedRxiv detailing the clinical benefits of masitinib for amyotrophic lateral sclerosis (ALS) patients before any complete loss of function [2][3] Group 1: Study Findings - The post-hoc subgroup analysis from the phase 2b/3 AB10015 study shows significant improvement in functional decline measured by the ALSFRS-R score, with a 4.04-point difference favoring masitinib over placebo (p=0.0065) [4][5] - A relative benefit of +20.2% on the CAFS score was observed compared to placebo (p=0.0290), surpassing the +13.8% benefit seen in the primary analysis [5] - Median progression-free survival (PFS) was extended by 9 months (p=0.0057) and median overall survival (OS) increased by 12 months (p=0.0192) compared to placebo, both improvements being more pronounced than those in the primary analysis [5] Group 2: Safety and Patient Population - Safety outcomes improved, with a reduction in serious adverse events from 27.6% to 22.6% in masitinib-treated patients [5] - The subgroup analyzed included patients with a score of at least 1 on all ALSFRS-R items at baseline, representing approximately 85% of the primary analysis population [3][5] Group 3: Future Studies - The findings from this analysis will inform the design of the confirmatory study AB23005, which targets patients prior to any complete loss of function to optimize the benefit-risk balance [2][3] - Study AB23005 is a prospective, multicenter, randomized, double-blind, placebo-controlled trial involving 408 ALS patients, aiming to confirm the efficacy and safety of masitinib [7][8]

Core Viewpoint - AB Science has successfully completed a private placement raising EUR 2.8 million to finance the clinical development of its drug candidate AB8939 for acute myeloid leukemia (AML) [2][4]. Use of Proceeds - The net proceeds from the private placement will primarily be used to complete phase 1 of the AB8939 program and to initiate an expansion study involving approximately 15 AML patients [4][5]. Financial Impact - The private placement strengthens the company's cash position, allowing it to meet its financing needs for 2025 and beyond [5]. Private Placement Details - The private placement involved the issuance of 2,477,877 new ordinary shares, each accompanied by a share warrant (BSA), without preferential subscription rights [6][7]. - The issue price of one ABSA is set at EUR 1.13, reflecting a 24.99% discount to the volume-weighted average price over the preceding three trading days [8][9]. Shareholding Structure - Post-private placement, the company's total share capital will amount to EUR 729,474.72, consisting of 66,184,793 ordinary shares, with potential dilution from the exercise of BSAs [13][15]. Trading Information - The new shares are expected to be admitted to trading on Euronext Paris on October 22, 2025, and will be assimilated to existing shares [18]. 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 already registered for veterinary use and is being developed for human medicine across various disease areas [25]. Drug Candidate Information - AB8939 is a synthetic microtubule-destabilizing drug candidate with broad anticancer activity, showing potential to overcome drug resistance commonly seen in chemotherapy [24].

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].

Financial and Corporate Situation - AB Science reported an operating deficit of €6.1 million as of December 31, 2024, a decrease of 55% compared to €13.4 million in 2023 [6][26] - The cash position stood at €8.0 million as of December 31, 2024 [6] - Operating income increased by 10% to €1.072 million in 2024 from €0.970 million in 2023 [27] - Operating expenses decreased by 50%, amounting to €7.244 million less than in 2023 [27][28] Clinical Development - AB Science provided updates on the AB8939 microtubule program, which targets relapsed/refractory acute myeloid leukaemia (AML) [3][4] - The Phase 1 study of AB8939 included 28 patients, assessing the maximum tolerated dose after 3 consecutive days of treatment, with a second stage nearing completion for 14 consecutive days [4][5] - AB8939 showed a 50% response rate against the MECOM gene rearrangement, which is associated with poor prognosis in AML [7][8] Masitinib Platform - Positive results were reported from the Phase 2 study of masitinib in COVID-19, with an odds ratio of 2.4 in favor of the treatment arm after 15 days [16][18] - The European Medicines Agency (EMA) issued a negative opinion for the conditional marketing authorization of masitinib in ALS [19] - A new confirmatory study for masitinib in ALS will be launched, targeting the best responders [21] Intellectual Property Developments - AB Science secured intellectual property rights for AB8939 in AML until 2036 and potentially until 2044 for specific chromosomal abnormalities [8] - New patents were granted for masitinib in the treatment of severe systemic mastocytosis, sickle cell disease, and other indications, extending protection until 2041 or 2042 [23][25][24] Capital Increase and Financial Strategy - A capital increase of €5 million was announced through the issuance of 5,368,725 new ordinary shares [31][34] - The proceeds from the capital increase will support AB Science's activities over the next twelve months [36] - The company has engaged in a Term Capital Increase Program (PACT) with Alpha Blue Ocean, which has provided additional funding [37] Market Position and Analyst Coverage - AB Science has received coverage initiation from DNA Finance and In Extenso Finance, with strong buy opinions indicating a compelling investment opportunity in the biotech sector [41][42]