Workflow
AB8939
icon
Search documents
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 receives regulatory approval from European countries to initiate third stage of Phase I/II study combining its molecule AB8939 with venetoclax for the treatment of AML
Globenewswire· 2025-07-30 05:46
Core Viewpoint - AB Science has received regulatory approval from several European countries to initiate the third stage of its Phase I/II study combining AB8939 with venetoclax for treating acute myeloid leukemia (AML), indicating potential advancements in treatment options for patients with relapsed/refractory AML [1][4]. Group 1: Study Details - The third stage of the study has been approved in France, Germany, Spain, and Greece, focusing on determining the maximum tolerated dose (MTD) of AB8939 [2]. - The first two stages of the Phase I study involved 28 and 13 patients, respectively, establishing the MTD of AB8939 at 21.3 mg/m² after both 3 and 14 consecutive days of treatment [3]. - The current stage will evaluate the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax, a standard treatment for AML [3][6]. Group 2: Treatment Rationale - The combination of AB8939 and venetoclax is expected to have low hematologic toxicity, potentially making it less toxic than the current standard treatment of azacitidine plus venetoclax [5]. - Both compounds target different mechanisms in cancer cells, which may lead to additive or synergistic effects in efficacy [5][9]. - AB8939 destabilizes microtubules, preventing cancer cell division, while venetoclax inhibits BCL2, promoting apoptosis in cancer cells, thus addressing resistance mechanisms [7][13]. Group 3: Market Potential - The estimated market potential for AML treatments exceeds €2 billion annually, with significant addressable markets in the United States, Europe, and Asia-Pacific [11][12]. - The total incidence of AML in the United States, Europe, and Asia-Pacific is approximately 79,100 cases, with a significant portion being poor responders to standard therapies [12][15]. Group 4: Intellectual Property and Regulatory Status - AB8939 is protected by patents until 2026, with potential extensions and additional protections for specific uses in AML, extending to 2044 for certain chromosomal abnormalities [16][18]. - The drug 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 US [19].
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 announces issuance of a Canadian patent protecting the composition of matter of AB8939, including its use in the treatment of acute myeloid leukemia, with protection until 2036
Globenewswire· 2025-06-12 05:59
Core Points - AB Science has announced the issuance of a Canadian patent for AB8939, which protects its composition and use in treating acute myeloid leukemia (AML) until 2036 [1] - The patent completes the intellectual property coverage for AB8939 across all key geographic areas, including Europe, USA, China, Japan, South Korea, India, Israel, Latin America, and Australia [2] - AB8939 is a novel microtubule destabilizer currently in early phase clinical trials for AML, with the first phase focusing on determining the maximum tolerated dose [3] - The drug is also eligible for regulatory data protection in Canada, preventing generic competition for 8 years post-approval, and has received orphan drug designation from EMA and FDA, providing additional market exclusivity [4] - A separate patent application has been filed to protect AB8939 for treating AML with specific chromosomal abnormalities, potentially extending protection until 2044 [5] - AB8939 targets cancer cells by destabilizing microtubules and inhibiting enzymes essential for cancer stem cell survival [6] - AB Science specializes in developing protein kinase inhibitors for diseases with high unmet medical needs and has a portfolio of molecules including masitinib [7][8]
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].
AB Science reports its revenues for the year 2024 and provides an update on its activities
Globenewswire· 2025-05-12 06:14
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]
AB Science announces that EMA granted orphan drug status to AB8939 for the treatment of acute myeloid leukemia
Globenewswire· 2025-04-23 16:59
Core Viewpoint - The European Medicines Agency (EMA) has granted orphan drug designation to AB8939 for the treatment of acute myeloid leukemia (AML), indicating its potential significant benefit over existing therapies [1][2]. Group 1: Orphan Drug Designation - AB8939 previously received orphan drug designation from the US FDA, and the EU designation is a significant milestone, suggesting that it offers substantial benefits to AML patients [2]. - The criteria for orphan drug designation at EMA are stringent, requiring evidence of significant benefit compared to existing treatments [2][4]. Group 2: Efficacy and Safety Data - Preclinical data from mouse models show that AB8939 provides a significant benefit over current therapies like cytarabine, azacitidine, and venetoclax [3]. - Preliminary efficacy and safety data from Phase 1 trials indicate that AB8939 is effective as a monotherapy with different treatment cycles [3]. - AB8939 demonstrates efficacy against drug-resistant AML cells, with 45% of vincristine-resistant and 66% of cytarabine-resistant cells responding to treatment [4]. Group 3: Mechanism of Action - AB8939 is a synthetic molecule that targets cancer cells by destabilizing microtubules essential for cell division and inhibiting enzymes crucial for cancer stem cell survival [6]. - The chemical name of AB8939 is '1-{4-[2-(5-ethoxymethyl-2-methylphenylamino)-oxazol-5-yl]phenyl}imidazolidin-2-one' [6]. Group 4: Benefits of Orphan Drug Designation - Orphan drug designation in the EU provides various benefits, including scientific advice on product development, access to centralized marketing authorization, and potential financial incentives [8]. - If approved, AB8939 will enjoy 10 years of marketing exclusivity from the date of registration, provided the orphan designation remains valid [8].