Duyuru • 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.

Pharmaceuticals Sektör Büyümesi	7.33%
Gelir büyüme oranı	-10.43%
Özkaynak getirisi	n/a
Net Marj	-132.62%
Sonraki Kazanç Güncellemesi	30 Sep 2026

Tarih	Gelir	Kazançlar	G+A Giderleri	Ar-Ge Giderleri
31 Dec 25	1	-2	2	-2
30 Sep 25	1	-5	3	1
30 Jun 25	1	-9	3	3
31 Mar 25	1	-8	3	4
31 Dec 24	1	-8	3	4
30 Sep 24	1	-7	3	5
30 Jun 24	1	-6	3	6
31 Mar 24	1	-9	3	8
31 Dec 23	1	-12	4	10
30 Sep 23	1	-14	3	11
30 Jun 23	1	-17	3	12
31 Mar 23	1	-15	3	13
31 Dec 22	1	-14	4	13
30 Sep 22	1	-15	4	14
30 Jun 22	1	-17	4	14
31 Mar 22	2	-16	4	13
31 Dec 21	2	-14	4	11
30 Sep 21	2	-13	4	12
30 Jun 21	2	-11	3	12
31 Mar 21	2	-13	3	12
31 Dec 20	2	-15	3	13
30 Sep 20	2	-16	3	12
30 Jun 20	2	-18	3	12
31 Mar 20	2	-20	3	14
31 Dec 19	2	-22	3	16
30 Sep 19	2	-25	3	19
30 Jun 19	2	-28	3	23
31 Mar 19	2	-27	3	25
31 Dec 18	2	-26	3	27
30 Sep 18	2	-25	3	27
30 Jun 18	2	-25	3	27
31 Mar 18	2	-26	3	27
31 Dec 17	2	-27	3	27
30 Sep 17	2	-27	3	26
30 Jun 17	2	-26	3	26
31 Mar 17	2	-27	3	27
31 Dec 16	2	-28	3	28
30 Sep 16	2	-28	4	27
30 Jun 16	2	-28	4	27
31 Mar 16	2	-28	4	25
31 Dec 15	2	-27	4	24
30 Sep 15	2	-24	4	21

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2026/09/09 15:02
Gün Sonu Hisse Fiyatı	2026/09/09 00:00
Kazançlar	2025/12/31
Yıllık Kazançlar	2025/12/31

Paket	Veri	Zaman Çerçevesi	Örnek ABD Kaynağı ^*
Şirket Finansalları	10 yıl	Gelir tablosu Nakit akış tablosu Bilanço	SEC Form 10-K SEC Form 10-Q
Analist Konsensüs Tahminleri	+3 yıl	Finansal tahminler Analist fiyat hedefleri	Analist Araştırma Raporları Blue Matrix
Piyasa Fiyatları	30 yıl	Hisse senedi fiyatları Temettüler, Bölünmeler ve Eylemler	ICE Piyasa Verileri SEC Form S-1
Sahiplik	10 yıl	En büyük hissedarlar İçeriden öğrenenlerin ticareti	SEC Form 4 SEC Form 13D
Yönetim	10 yıl	Liderlik ekibi Yönetim Kurulu	SEC Form 10-K SEC Form DEF 14A
Önemli Gelişmeler	10 yıl	Şirket duyuruları	SEC Form 8-K

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

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