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	no data
Eigentum des Geschäftsführers	n/a
Durchschnittliche Amtszeit des Managements	keine Daten
Durchschnittliche Amtszeit der Vorstandsmitglieder	5.1yrs

Name	Position	Amtszeit	Vergütung	Eigentümerschaft
Alain Moussy	Co-Founder	25yrs	€599.00k	18.97% € 10.6m
Stéphane Ledermann	CEO & Chairman of the Board	no data	keine Daten	keine Daten
Christian Auclair	Member of Scientific Committee	no data	€13.00k	0.032% € 18.1k
Patrick Moussy	Director	25yrs	keine Daten	0.0013% € 698.1
Cecile Guillebon	Independent Director	5.1yrs	keine Daten	0.000060% € 33.5
Catherine Johnston-Roussillon	Independent Director	5.1yrs	keine Daten	0.012% € 6.9k
Guillemette Latscha	Independent Director	5.1yrs	keine Daten	0.012% € 6.9k

Daten	Zuletzt aktualisiert (UTC-Zeit)
Unternehmensanalyse	2026/07/27 11:14
Aktienkurs zum Tagesende	2026/07/27 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

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