PRESS RELEASE
AB SCIENCE PRESENTS ITS ANNUAL FINANCIAL RESULTS AS OF 31 DECEMBER 2025 AND KEY EVENTS FOR THE PERIOD
- Financial and corporate position
- Operating loss of €3.8 million as of 31 December 2025, down 38% compared with the 2025 financial year (excluding non-recurring items)
- Cash position of €10.2 million as of 31 December 2025, plus €3.2 million from the private placement carried out in April 2026
- Final agreement on the renegotiation of the repayment terms of its loans with all financial creditors
- Clinical development: focus of resources on Phase 3 of masitinib in ALS and Phase 1 of AB8939 in acute myeloid leukaemia (AML)
Paris, 13 May 2025, 7pm CET
AB Science SA (Euronext – FR0010557264 – AB) today announces its annual financial results as of 31 December 2025 and provides an update on its activities.
KEY EVENTS RELATED TO CLINICAL DEVELOPMENT DURING 2025 AND SINCE 31 DECEMBER 2025
- In amyotrophic lateral sclerosis (ALS), the masitinib development programme reached several key milestones during 2025 and 2026
i) Approval by several European countries to initiate the confirmatory Phase 3 trial
AB Science announced in July 2025 that the confirmatory Phase 3 trial with masitinib in amyotrophic lateral sclerosis (ALS) (study AB23005) had been authorised by an initial group of European countries (Spain, Greece, Slovenia) in Stage 2 of the Clinical Trials Information System (CTIS). This authorisation follows the EMA’s validation of the harmonised protocol approved at the end of Phase 1 of the CTIS, as well as the authorisation received from the FDA. It now enables AB Science to initiate this registration study in Europe and the United States.
The AB23005 study is a prospective, multicentre, randomised, double-blind, placebo-controlled trial with two parallel groups, designed to confirm the efficacy and tolerability of masitinib (at a dose of 4.5 mg/kg/day in combination with riluzole) compared with riluzole plus placebo after 48 weeks of treatment in amyotrophic lateral sclerosis.
The study is to include 408 patients (1:1 randomisation) with ALS, with a so-called normal rate of disease progression (i.e. a decline in functional score of less than 1.1 points per month) and who have not yet experienced 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, as taking this medication is a stratification factor.
This design was validated during discussions with European health authorities, particularly regarding the criteria for the optimal population selected for the confirmatory study:
- Patients without rapid progression: Experts from the EMA’s Scientific Advisory Group on Neurology (SAG-N) considered the categorisation of the study population to include normal progressors, using an average rate of change in the ALSFRS-R of less than 1.1 points per month as the threshold, as clinically relevant and consistent with the expected course of the disease, and therefore acceptable provided it is predefined, which is the case for this study.
- Patients without complete loss of function: The SAG-N experts considered that the ALSFRS-R scale is widely used in clinical practice and that administration criteria are available to healthcare professionals. Consequently, the subgroup of patients with very severe ALS (who score zero on at least one of the 12 individual items of the ALSFRS-R) can be easily identified in clinical practice.
In this subgroup, defined as patients prior to complete loss of function and with normal disease progression (DFS<1.1), which corresponds to the optimal population of best responders to masitinib and to be included in the AB23005 study, the AB10015 study generated extremely robust results, with a median survival increase of +12 months.
This optimal population represents approximately 75% of the total patient population.
The optimal population comprised approximately 90 patients per treatment group in the AB10015 study. The effect of masitinib was statistically significant (p=0.0290) on the CAFS endpoint, which is the endpoint recognised by the FDA.
The AB23005 study will recruit approximately 200 patients per treatment group—more than double the number—in order to achieve strong statistical power for this trial and maximise the chances of statistical success.
ii) Publication highlighting the clinical benefit of masitinib
AB Science announced in December 2025 the publication of a new article on the preprint platform MedRxiv, presenting a post-hoc subgroup analysis of the Phase 2b/3 AB10015 study evaluating masitinib in patients with amyotrophic lateral sclerosis prior to complete loss of function. This article, entitled ‘Efficacy and safety of masitinib in amyotrophic lateral sclerosis patients prior to loss of functionality: a subgroup analysis optimising the benefit-risk profile of masitinib‘.
In this population, the analyses presented show :
- A significant improvement in functional decline as measured by the ALSFRS-R score, with a difference of 4.04 points in favour of masitinib compared with placebo (p=0.0065)
- A significant benefit on the CAFS (relative benefit +20.2%, p=0.0290)
- A 9-month increase in median progression-free survival (PFS) (p=0.0057)
- An increase in median overall survival (OS) of 12 months (p=0.0192)
These results were taken into account in the design of the confirmatory AB23005 study, which targets a population that optimises the benefit-risk ratio in order to increase the study’s chances of success.
iii) Identification of a potential biomarker for masitinib’s activity on microglia
AB Science announced in February 2026 the identification of a potential biomarker to assess the activity of masitinib in the pathological involvement of microglia in amyotrophic lateral sclerosis.
The main characteristics of this newly identified biomarker are as follows:
- It is a blood (plasma) biomarker, which has the advantage of being easy to collect and can be accurately measured by ELISA (enzyme-linked immunosorbent assay).
- It is produced by pro-inflammatory microglia.
- It activates microglia and astrocytes and thus acts as an activator contributing to a harmful feedback loop of neuroinflammation.
- It is also released by mast cells, thereby establishing a link between mast cells and microglia, which are the two main cellular targets of masitinib.
- It enables the prediction of survival in ALS, which may explain why masitinib could prolong survival in certain specific patients.
- In-house experiments have shown that this biomarker is reduced by masitinib when mast cells and microglia are activated in vitro, highlighting masitinib’s specific and potent activity on mast cells and microglia.
iv) Binding offer for clinical trial financing insurance (CTFI)
AB Science announced in February 2026 that it had received a firm offer to underwrite a clinical trial financing insurance policy from Medical & Commercial International Ltd. (MCI), Lloyd’s Syndicate 1902, for its pivotal Phase III trial AB23005 evaluating masitinib (AB1010) in combination with standard of care treatment in amyotrophic lateral sclerosis (ALS). The placement was arranged by Acrisure Re UK, in collaboration with its subsidiary Acrisure Re Netherlands. The policy provides excess-free cover, with a liability limit of €25 million, extendable to €39 million, intended to cover the full financial costs associated with clinical failure. It takes effect on the date of enrolment of the first patient, subject to AB Science securing the necessary funding for the study and payment of the premium of approximately €8 million (an amount including the insurance premium, taxes and brokerage fees, for a liability limit of €25 million; this premium may amount to approximately €13 million for a liability limit of €39 million). The offer is valid until 31 December 2026.
The events covered include efficacy failure according to FDA/EMA criteria, safety failure, recruitment failure, regulatory suspension, GCP or data integrity violations, premature termination recommended by the independent committee, as well as manufacturing issues (CMC).
This structure represents a significant reduction in the risk profile of the SLA programme and the Company, with three benefits for shareholders: (i) protection of invested capital up to €25 million in the event of failure; (ii) external validation of the trial design and regulatory pathway through the independent due diligence conducted by the insurer; (iii) improved capital efficiency and terms of access to debt and equity financing.
- AB Science has continued to strengthen the intellectual property portfolio for masitinib in progressive forms of multiple sclerosis, sickle cell disease and prostate cancer
AB Science announced in January 2026 that the Japan Patent Office had officially granted a patent for methods of treating progressive multiple sclerosis (MS) with its lead compound, masitinib. This new patent (JP 7788154) ensures the protection of masitinib’s intellectual property until February 2041. This is the first country to grant a patent protecting the use of masitinib in progressive forms of MS. AB Science has followed the same methodology for the protection of masitinib in progressive forms of MS as for the use of masitinib in ALS. The latter patent has been granted worldwide. AB Science is optimistic about its prospects of securing protection for the use of masitinib in progressive MS on a global scale.
AB Science announced in April 2025 that the US Patent and Trademark Office had issued a notice of acceptance for a patent covering methods (i.e. a medical use patent) for treating sickle cell disease with its lead compound, masitinib, based on preclinical results. This new US patent protects the intellectual property rights for masitinib in this indication until November 2040 and further strengthens the intellectual property rights for masitinib, following a notice of acceptance received from the European Patent Office in October 2024 for the same patent.
AB Science announced in January 2026 that the US Patent and Trademark Office (USPTO) had issued a Notice of Acceptance (NOA) for a patent relating to methods for treating metastatic hormone-resistant prostate cancer (mCRPC) with its lead compound, masitinib (US 18/040884). Once granted, this new US secondary medical use patent will ensure the protection of masitinib’s intellectual property (IP) in mCRPC until May 2042. A NOA means that the USPTO intends to grant the patent application after completing certain procedural formalities. The US NOA is issued after an examiner has confirmed that the patent application meets all patentability requirements. This new US patent complements the coverage already granted in Europe (EP4175639). Equivalent patent applications have also been filed in other major international markets.
- The confirmatory Phase 3 trial in hormone-resistant metastatic prostate cancer has been authorised by the FDA and the EMA
AB Science announced in July 2025 that a Phase 3 confirmatory trial with masitinib in hormone-resistant metastatic prostate cancer (AB22007 trial) has been authorised by the FDA and the EMA (harmonised protocol approved following Phase 1 of the Clinical Trials Information System, CTIS), with a biomarker targeting patients whose metastatic disease is less advanced.
Study AB22007 is a prospective, multicentre, randomised, double-blind, placebo-controlled, parallel-group Phase 3 study designed to confirm the efficacy and tolerability of docetaxel (administered intravenously at a dose of 75 mg/m² and combined with prednisone for up to 10 cycles) combined with masitinib at a dose of 6.0 mg/kg/day, compared with docetaxel combined with a placebo in metastatic hormone-resistant prostate cancer (mCRPC).
- The AB8939 development programme also reached several key milestones in 2025 and 2026
i) Approval in Europe of the third of four stages of the Phase 1/2 study in relapsed/refractory acute myeloid leukaemia (AML)
In July 2025, AB Science announced the approval of the third of four stages of the Phase 1/2 trial (AB18001) with the compound AB8939 in adult patients with relapsed or refractory acute myeloid leukaemia (AML).
The third stage of the study has been authorised in France, Germany, Spain and Greece.
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 maximum tolerated dose (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.
- Stage 3: Determination of the MTD following 14 consecutive days of treatment with AB8939 in combination with venetoclax.
- Stage 4: Determination of the MTD following 14 consecutive days of treatment with AB8939 in combination with venetoclax and azacitidine.
The first two stages of Phase 1 were completed with 28 and 13 patients enrolled respectively, and established the MTD of AB8939 after 3 consecutive days of treatment (21.3 mg/m²) and after 14 consecutive days of treatment (21.3 mg/m²).
The third phase now involves evaluating the maximum tolerated dose following 14 consecutive days of treatment with AB8939 in combination with venetoclax, a standard-of-care treatment for AML.
The AB8939 + venetoclax combination offers several potential benefits:
- Both molecules are haematologically low-toxicity. This combination could therefore represent a less toxic option than azacitidine plus venetoclax as first-line treatment for AML.
- These two molecules act on different and complementary targets within cancer cells, which could have an additive, or even synergistic, effect in terms of efficacy.
Treatments for AML represent an estimated market potential of over €2 billion per year.
ii) Announcement of the fourth consecutive response with the AB8939 + venetoclax combination
In January 2026, AB Science announced the fourth consecutive response with the AB8939 + venetoclax combination …