Ankündigung • Apr 18

AB Science Provides Update on Clinical Development Program

AB Science SA provided an update on its clinical development program. AB Science has received a binding offer for a Clinical Trial Funding Insurance policy from Medical & Commercial International Ltd. (MCI), Lloyd’s Syndicate 1902, for its Phase III clinical trial AB23005, evaluating masitinib (AB1010) as an add-on therapy in Amyotrophic Lateral Sclerosis (ALS). The policy, effective from the date the first patient is enrolled, provides coverage for a limit of liability of EUR 25,000,000 and potentially up to EUR 39,000,000 against the full financial cost of clinical failure, with no deductible. This placement was arranged by Lloyd’s broker Acrisure Re UK, in conjunction with its European affiliate, Acrisure Re Netherlands. Clinical Trial Funding Insurance (CTFI) is a specialized financial product that reimburses a biopharmaceutical company for the costs incurred in running a clinical trial, in the event that trial fails to meet its pre-defined, policy specific, success criteria (often aligned to the trial protocol end points). Phase III programs — the pivotal, large-scale studies required before regulatory approval — typically cost millions of euros and can fail for reasons entirely outside a sponsor’s control, including lack of efficacy, unexpected safety findings, regulatory actions, or supply chain disruptions. CTFI allows AB Science to transfer a significant portion of this financial risk to MCI in exchange for a one-time up-front premium. Two scenarios are then possible: either the study is a success and the value generated will be large, or the study is a failure and AB Science will get the full cost of the phase 3 study back (excluding the premium). This covers the following situations: Efficacy Failure: the phase 3 fails to meet the FDA or the EMA criteria of success, defined by the policy. Safety Failure: the drug raises unacceptable safety concerns in the ALS patient population. Recruitment Failure: inability to enroll or retain the required number of patients within the policy period. Regulatory Action (Clinical Hold): the FDA or an equivalent authority suspends or terminates the trial. GCP /Data Integrity Breach: protocol violations by a CRO or clinical investigator that render trial data unacceptable to regulators. Early Trial Termination: the Independent Data Monitoring Committee recommends stopping the trial on safety or efficacy grounds. Manufacturing (CMC) Issues: defects in drug production or supply chain disruption preventing trial completion. For shareholders, this insurance structure delivers three concrete benefits. First, capital protection: a failed trial could destroy EUR 25 million of invested capital; the policy allows AB Science to recover up to EUR 25 million of those costs (excluding the premium) from the insurer, substantially limiting the financial damage to the company. Second, third-party validation: the insurance underwriters conduct rigorous independent due diligence before underwriting these policies, and their willingness to do so at a defined premium constitutes institutional confidence in the trial design, the regulatory pathway, and the underlying science. Third, improved capital efficiency: by capping the downside of the trial, the insurance lowers the company’s risk profile for debt and equity financing, potentially improving the terms under which AB Science can access capital to fund parallel activities. The recruitment of new patients in AB Science studies has been voluntarily halted while AB Science was negotiating with the insurer and was having on-going exchanges with European health authorities. To pursue the phase 3 clinical development in multiple sclerosis and Alzheimer’s disease through partnerships. Maximizing the potential in these two indications required established sales and marketing capabilities, which AB Science does not have at this time. To prioritize AB Science clinical development program on the masitinib phase 3 in amyotrophic Lateral Sclerosis (ALS) and AB8939 phase 1 in acute myeloid leukemia (AML). Given the current stage of its clinical pipeline, such temporary halt has no material impact on AB Science’s current operations. The phase 3 in ALS is yet to be started. The phase 1 of AB8939 recently completed its step 3 (Determination of the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax) and initiation of step 4 (Determination of MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax and azacitidine) is pending regulatory approval. However, for the launch of the ALS Phase III clinical trial and the pursuance of its AB8939 program, AB Science will strengthen its organization to meet the demands and address the concerns of the health authorities regarding the adequation of resources. The CFTI binding offer has contributed to this strategic prioritization, with a focus on the ALS Phase III clinical trial that has been de-risked. Study AB23005 is a prospective, multicenter, randomized, double-blind, placebo-controlled, two-arm study in patients with amyotrophic lateral sclerosis (ALS), to confirm the efficacy and safety of masitinib (at a dose of 4.5 mg/kg/day in combination with riluzole) as compared against riluzole in combination with placebo after 48 weeks of treatment. The study will include 408 patients (randomized 1:1) with ALS, with normal disease progression (i.e., functional decline of less than 1.1 points per month) and no total loss of function (i.e., a score of at least 1 on each of the 12 items of the ALSFRS-R score). US patients receiving edaravone will also be eligible to participate in the study, with the use of this drug being a stratification factor. Study AB18001, titled ‘A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous of AB8939 in patients with Relapsed/Refractory Acute Myeloid Leukemia’, has a multi-stage design. The first part is a dose escalation study that aims to determine the safety and tolerability of intravenous AB8939, and to determine the recommended dose for the expansion study. The objective of the Phase 1 study is to determine the maximum tolerated dose (MTD) for different treatment stages of AB8939. Stage 1: Determination of the MTD after 3 consecutive days of treatment with AB8939 alone. Stage 2: Determination of the MTD after 14 consecutive days of treatment with AB8939 alone. Step 3: Determination of the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax. Stage 4: Determination of MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax and azacitidine.

Prozentsatz des Geschäftsführergehalts	n/a
Amtszeit als Geschäftsführer	less than a year
Eigentum des Geschäftsführers	n/a
Durchschnittliche Amtszeit des Managements	keine Daten
Durchschnittliche Amtszeit der Vorstandsmitglieder	5.3yrs

Name	Position	Amtszeit	Vergütung	Eigentümerschaft
Christian Auclair	Deputy MD & Director	1.3yrs	€13.00k	0.032% € 19.0k
Stéphane Ledermann	CEO & Director	less than a year	keine Daten	keine Daten
Patrick Moussy	Director	25.2yrs	keine Daten	0.0013% € 730.1
Cecile Guillebon	Independent Director	5.3yrs	keine Daten	0.000060% € 35.0
Catherine Johnston-Roussillon	Independent Director	5.3yrs	keine Daten	0.012% € 7.2k
Guillemette Latscha	Independent Director	5.3yrs	keine Daten	0.012% € 7.2k

Daten	Zuletzt aktualisiert (UTC-Zeit)
Unternehmensanalyse	2026/09/14 16:45
Aktienkurs zum Tagesende	2026/09/11 00:00
Gewinne	2025/12/31
Jährliche Einnahmen	2025/12/31

Paket	Daten	Zeitrahmen	Beispiel US-Quelle ^*
Finanzdaten des Unternehmens	10 Jahre	Gewinn- und Verlustrechnung Kapitalflussrechnung Bilanz	SEC-Formular 10-K SEC-Formular 10-Q
Konsensschätzungen der Analysten	+3 Jahre	Finanzielle Vorausschau Kursziele der Analysten	Analysten Research Berichte Blue Matrix
Marktpreise	30 Jahre	Aktienkurse Dividenden, Splits und Aktionen	ICE-Marktdaten SEC-Formular S-1
Eigentümerschaft	10 Jahre	Top-Aktionäre Insiderhandel	SEC-Formular 4 SEC-Formular 13D
Verwaltung	10 Jahre	Das Führungsteam Direktorium	SEC-Formular 10-K SEC-Formular DEF 14A
Wichtige Entwicklungen	10 Jahre	Ankündigungen des Unternehmens	SEC-Formular 8-K

Analyst	Einrichtung
Michael Ryskin	BofA Global Research
Sébastien Malafosse	ODDO BHF Corporate & Markets
Justin Steven Smith	Societe Generale Cross Asset Research

AB Science Management

Management Kriterienprüfungen 1/4

Wichtige Informationen

Jüngste Management Updates

Less than half of directors are independent

Insufficient new directors

AB Science S.A., Annual General Meeting, Jun 30, 2026

AB Science S.A., Annual General Meeting, Jun 30, 2025

Insufficient new directors

AB Science S.A., Annual General Meeting, Jun 26, 2024

Recent updates

AB Science S.A. has completed a Follow-on Equity Offering in the amount of €14.200003 million.

Less than half of directors are independent

AB Science S.A. to Report First Half, 2026 Results on Sep 30, 2026

New minor risk - Share price stability

AB Science SA Provides Update on Clinical Program, Suspends Non-Priority Clinical Trials and Focuses on Ab8939 and Masitinib Programs

Insufficient new directors

AB Science S.A. has completed a Follow-on Equity Offering in the amount of €2.294 million.

AB Science Reports Completion of Step 3 of Phase 1 Evaluating Combination of Ab8939 with Venetoclax for Treatment of Refractory or Relapsed Acute Myeloid Leukemia

AB Science Patent For Masitinib In The Treatment Of Metastatic Castrate Resistant Prostate Cancer Formally Granted In The United States With Protection Until 2042

New minor risk - Shareholder dilution

AB Science S.A., Annual General Meeting, Jun 30, 2026

AB Science S.A. announced that it has received $2.989368 million in funding

Full year 2025 earnings released: €0.03 loss per share (vs €0.15 loss in FY 2024)

New minor risk - Shareholder dilution

New minor risk - Financial data availability

AB Science Announces New Publication Demonstrating Substantial Survival Benefits and Preserved Quality of Life with Masitinib in Amyotrophic Lateral Sclerosis Patients

AB Science Provides Update on Clinical Development Program

New minor risk - Market cap size

AB Science SA Announces the Identification of A Plasma Biomarker That Indifies the Activity of Masitinib in Amyotrophic Lateral Sclerosis

AB Science Sa Reports Fourth Consecutive Case of Response from Phase 1 Data for the Combination of Ab8939 with Venetoclax for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia

AB Science S.A. has completed a Follow-on Equity Offering in the amount of €2.800001 million.

First half 2025 earnings released: €0.09 loss per share (vs €0.086 loss in 1H 2024)

New minor risk - Market cap size

New major risk - Share price stability

New minor risk - Shareholder dilution

AB Science S.A. announced that it expects to receive €2.550001 million in funding

AB Science SA 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

AB Science Receives Approval from Several European Countries to Initiate the Confirmatory Phase 3 Study of Masitinib in ALS

AB Science S.A. has completed a Follow-on Equity Offering in the amount of €1.925003 million.

AB Science SA Receives FDA and EMA Authorization for Confirmatory Phase 3 Trial in Metastatic Castrate-Resistant Prostate Cancer

New minor risk - Share price stability

AB Science SA Announces New Peer-Reviewed Data Provide Strong Evidence Supporting Masitinib Potential for the Treatment of Alzheimer's Disease

Price target decreased by 26% to €2.54

AB Science SA Announces EMA Approval of Masivet Shelf-Life Extension to 4 Years

New minor risk - Market cap size

AB Science S.A., Annual General Meeting, Jun 30, 2025

AB Science Receives Chinese Patent Protecting Masitinib in the Treatment of Covid-19 Until 2041, Adding One More Indication with Long Term Intellectual Property Protection

AB Science SA Reports New Publication in the Scientific Journal PLOS One

AB Science S.A. Announces Positive Results from the Phase 2 Study of Masitinib in Covid-19

New major risk - Revenue and earnings growth

Full year 2024 earnings released: €0.15 loss per share (vs €0.24 loss in FY 2023)

AB Science S.A. to Present New Data from Masitinib Clinical Program in Als in Two Presentations At the 2025 ENCALS Annual Meeting

New minor risk - Financial data availability

AB Science SA Receives Notice of Allowance for Unites States Patent Covering Masitinib Until 2040 in the Treatment of Sickle Cell Disease

AB Science S.A. to Report First Half, 2025 Results on Sep 30, 2025

New major risk - Revenue and earnings growth

AB Science Provides an Update on Its Ab8939 Program in Acute Myeloid Leukemia

New minor risk - Share price stability

AB Science Receives Notice of Allowance for European Patent Covering Masitinib Until 2040 in the Treatment of Sickle Cell Disease

First half 2024 earnings released: €0.09 loss per share (vs €0.22 loss in 1H 2023)

AB Science Announces Positive Results of Its Phase 2 Study Evaluating Masitinib in Covid-19

Insufficient new directors

New minor risk - Market cap size

AB Science S.A., Annual General Meeting, Jun 26, 2024

Full year 2023 earnings released

New minor risk - Financial data availability

AB Science Announces Eligibility granted by Health Canada for Reconsideration Request for Masitinib in ALS

Price target decreased by 27% to €6.90

AB Science S.A. to Report First Half, 2024 Results on Sep 30, 2024

AB Science Receives Notice of Allowance for European Patent Covering masitinib Until 2036 in the Treatment of mastocytosis

First half 2023 earnings released: €0.22 loss per share (vs €0.15 loss in 1H 2022)

New minor risk - Financial data availability

New minor risk - Financial data availability

New minor risk - Shareholder dilution

AB Science S.A. Receives Notice of Allowance for European Patent Covering Masitinib in the Treatment of Metastatic Castrate Refractory Prostate Cancer (mCRPC)

Full year 2022 earnings released: €0.29 loss per share (vs €0.30 loss in FY 2021)

AB Science S.A. to Report Fiscal Year 2022 Results on Apr 28, 2023

First half 2022 earnings released: EPS: €0 (vs €0.099 loss in 1H 2021)

First half 2021 earnings released: €0.099 loss per share (vs €0.23 loss in 1H 2020)