AB SCIENCE PRESENTS ITS FINANCIAL RESULTS FOR THE FIRST HALF OF 2025 AND KEY EVENTS DURING THE PERIOD

• Financial and corporate situation
  • Operating deficit reduced by 24% compared to the first half of 2024, amounting to €2.7 million as of June 30, 2025
  • Capital increase through private placements for a total amount of €6.3 million
    
• Clinical development
  
  • Masitinib platform:
    • Authorization from several European countries for the confirmatory Phase 3 study with masitinib in amyotrophic lateral sclerosis
    • FDA and EMA authorization for the Phase 3 confirmatory study with masitinib in metastatic hormone-resistant prostate cancer
    • New data demonstrating the efficacy of masitinib in Alzheimer's disease
    • U.S. patent granted covering masitinib until 2040 for the treatment of sickle cell disease
  • Microtubule platform:
    • Regulatory approval in European countries to initiate the third stage of Phase I/I combining its AB8939 molecule with Venetoclax in the treatment of acute myeloid leukemia
    • Orphan drug designation by the EMA for the molecule AB8939 in the treatment of acute myeloid leukemia (AML)
    • Granting of a Canadian patent protecting the composition of AB8939, including its use in the treatment of acute myeloid leukemia, with protection until 2036

Paris, October 10, 2025, 6pm CET

AB Science SA (Euronext - FR0010557264 - AB) today announces its half-year financial results as of June 30, 2025, and provides an update on its activities.

CONSOLIDATED FINANCIAL RESULTS FOR THE FIRST HALF OF 2025

Operating income as of June 30, 2025, corresponds to a loss of €2,728,000, compared to a loss of €3,582,000 as of June 30, 2024, representing a decrease in the operating deficit of €854,000 (23.8%).

• Operating income consists exclusively of revenue from the sale of a veterinary medicine. Revenue was down compared to June 30, 2024, amounting to €515 thousand as of June 30, 2025, compared to €560 thousand as of June 30, 2024. This decrease in operating revenue over the period compared to the previous period is due to a temporary decline in sales of Masivet at a dose of 50mg, following the repackaging of treatment units due to the European Medicines Agency (EMA) approving the extension of the shelf life of the 50mg dose from 36 to 48 months.
• Operating expenses decreased by 21.7% between the first half of 2024 and the first half of 2025. These changes are mainly related to changes in research and development expenses and administrative expenses. This decrease reflects internal and external expenses following the implementation of the partnership search strategy for the continued clinical development of masitinib.
• Administrative expenses are the second largest contributor to operating expenses. They decreased by 31.1% between the first half of 2025 and the first half of 2024, amounting to €893 thousand for the first half of 2025 compared to €1,295 thousand for the first half of 2024.
• The financial result corresponds to a loss of €2,448 thousand for the first half of 2025, compared to a loss of €887 thousand for the first half of 2024. This includes, in particular, the change in conditional advances of €1,926 thousand, of which €333 thousand relates to the APAS-IPK advance and €1,594 thousand relates to the ROMANE advance. As of June 30, 2025, financial income mainly relates to foreign exchange gains of €138 thousand and investment income of €74 thousand. Other financial expenses (€129 thousand) mainly relate to:
  • Banking services and commissions and loan issuance costs of €52 thousand,
  • The cost of issuing the EIB loan: a loss of €55 thousand.

The net loss at June 30, 2025 amounted to €5,177 thousand, compared with a loss of €4,469 thousand at June 30, 2024, representing an increase of 15.8% for the reasons mentioned above.

The following table summarizes the consolidated financial statements for the first half of 2025 prepared in accordance with IFRS, and comparative information with the first half of 2024:

KEY EVENTS RELATED TO CLINICAL DEVELOPMENT DURING THE FIRST HALF OF 2025 AND SINCE JUNE 30, 2025

Authorization from several European countries for the Phase 3 confirmatory study with masitinib in amyotrophic lateral sclerosis

In July 2025, AB Science announced that the Phase 3 confirmatory study with masitinib in amyotrophic lateral sclerosis (ALS) (study AB23005) had been authorized by an initial group of European countries (Spain, Greece, Slovenia) in stage 2 of the Clinical Trials Information System (CTIS). This authorization follows the EMA's validation of the harmonized protocol approved at the end of Phase 1 of the CTIS and the authorization 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, multicenter, randomized, double-blind, placebo-controlled, two-arm Phase 3 study designed to confirm the efficacy and safety of masitinib (at a dose of 4.5 mg/ randomized, double-blind, placebo-controlled, two-arm study designed to confirm the efficacy and safety of masitinib (at a dose of 4.5 mg/kg/day in combination with riluzole) compared to riluzole combined with a placebo after 48 weeks of treatment in amyotrophic lateral sclerosis.

The study will include 408 patients (1:1 randomization) with ALS, with a normal disease progression rate (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). American patients receiving Edaravone will also be eligible to participate in the study, as taking this drug is a stratification factor.

This design has been validated in discussions with European health authorities, particularly with regard to the criteria for the optimal population selected for the confirmatory study.

FDA and EMA approval for the Phase 3 confirmatory study with masitinib in metastatic hormone-resistant prostate cancer

AB Science announced in July 2025 that a Phase 3 confirmatory study with masitinib in metastatic hormone-resistant prostate cancer (study AB22007) had been authorized by the FDA and EMA (harmonized protocol approved at the end of 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, multicenter, randomized, double-blind, placebo-controlled, two-arm Phase 3 study designed to confirm the efficacy and safety 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 to docetaxel combined with a placebo in metastatic hormone-resistant prostate cancer (mCRPC).

New data demonstrating the efficacy of masitinib in Alzheimer's disease

AB Science announced in June 2025 that a new peer-reviewed study conducted by an independent research team based in China (Guangdong Pharmaceutical University and Sun Yat-sen University) presents new evidence demonstrating that masitinib offers a promising new approach for the treatment of Alzheimer's disease, particularly its most common form, sporadic Alzheimer's disease, which accounts for more than 95% of all cases.

In this study, researchers used a proven mouse model that replicates the cognitive and behavioral symptoms of sporadic Alzheimer's disease. When treated with masitinib, the mice showed marked improvements in memory, learning, smell, and anxiety behaviors, all of which are early indicators of Alzheimer's disease progression.

The authors emphasized that this is the first study to demonstrate that masitinib attenuates sporadic Alzheimer's disease pathology through a dual mechanism of cognitive enhancement and neuroprotection.

U.S. patent granted for masitinib until 2040 for the treatment of sickle cell disease

AB Science announced in April 2025 that the US Patent 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 molecule, masitinib, based on preclinical results. This new US patent protects the intellectual property of the masitinib web e in this indication until November 2040 and further strengthens the intellectual property of masitinib, following a notice of acceptance received from the European Patent Office in October 2024 for the same patent.

Regulatory approval from European countries to initiate the third stage of Phase I/II trials combining its AB8939 molecule with Venetoclax in the treatment of acute myeloid leukemia

In July 2025, AB Science announced the authorization of the third of four stages of the Phase I/II study (AB18001) with the AB8939 molecule in adult patients with relapsed/refractory acute myeloid leukemia (AML).

The third stage of the study has been authorized 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 after 14 consecutive days of treatment with AB8939 in combination with venetoclax.
• Step 4: Determination of the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax and azacitidine.

The combination of AB8939 + venetoclax has several potential benefits:

• Both molecules have low hematological toxicity. This combination could therefore be less toxic than azacitidine + venetoclax as a first-line treatment for AML.
• These two molecules act on different and complementary targets in cancer cells, which could have an additive or even synergistic effect in terms of efficacy.

Orphan drug designation from the EMA for the molecule AB8939 in the treatment of acute myeloid leukemia (AML)

In April 2025, AB Science announced that the molecule AB8939 had been granted orphan drug designation by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) for the treatment of acute myeloid leukemia (AML).

The AB8939 molecule had already obtained orphan drug designation from the US Food and Drug Administration (FDA) for AML.

Granting of a Canadian patent protecting the composition of AB8939, including its use in the treatment of acute myeloid leukemia, with protection until 2036

AB Science announced in June 2025 that the Canadian Patent Office had granted a patent (CA 2975644) protecting the composition of matter of AB8939, as well as closely related compounds, until 2036. This patent also covers the use of AB8939 in the treatment of hematological disorders and/or proliferative disorders and provides strong global protection for the AB8939 clinical development program, including the treatment of acute myeloid leukemia (AML).

The issuance of this patent also completes the intellectual property coverage for AB8939 and AML in all geographic areas where AB8939 may be commercialized.

OTHER CORPORATE INFORMATION FOR THE FIRST HALF OF 2025 AND SINCE JUNE 30, 2025

Capital increase through private placements for a total amount of €6.3 million

AB Science announced in May, June, and July 2025 a capital increase for €1.8 million, €1.925 million, and €2.55 million, respectively.

The proceeds from the Private Placement will provide AB Science with the additional resources needed to finance its ongoing activities, primarily the continued clinical development of the AB8939 program.

Agreement in principle reached on a two-year deferral of repayment of state-guaranteed loans

In June 2025, AB Science announced that an agreement in principle had been reached with its financial creditors to defer the repayment of its bank debt (totaling approximately €3.7 million at the start of the conciliation procedure in January 2025) for 24 months. The implementation of this agreement is conditional upon the deferral of at least 12 months of the repayment of a loan taken out with the EIB (for a total amount of €12 million in principal, initially repayable in January and December 2028). The Company is continuing its discussions with the EIB to obtain this deferral.

Partial payment of the 2023 Research Tax Credit 2023 by the tax administration in 2025, for an amount of €2.934 million

About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development, and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action is crucial in cell signaling. Our programs target only diseases with high unmet medical needs, which are often fatal with low survival rates, rare, or resistant to first-line treatment.
AB Science has developed its own portfolio of molecules, and its flagship molecule, masitinib, has already been registered for veterinary use and is being developed for use in humans in oncology, neurodegenerative diseases, inflammatory diseases, and viral diseases. The Company is headquartered in Paris and is listed on Euronext Paris (Ticker: AB).

For more information about the Company, visit the website:

Forward-looking statements – AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements regarding projects, objectives, intentions, and expectations concerning financial results, events, future operations, services, product development and potential, or future performance.
These forward-looking statements can often be identified by the words "expect," "anticipate," "believe," "intend," "estimate," or "plan," as well as other similar terms. Although AB Science believes that these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties, which are difficult to predict and generally beyond the control of AB Science, which may cause actual results and events to differ materially from those expressed, implied or predicted in the forward-looking information and statements. These risks and uncertainties include, in particular, the uncertainties inherent in the development of the Company's products, which may not be successful, or in the granting of marketing authorizations by the competent authorities, or more generally any factors that may affect the marketability of the products developed by AB Science, as well as those developed or identified in public documents published by AB Science. AB Science undertakes no obligation to update forward-looking information and statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the AMF's General Regulations.

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• AB SCIENCE press release S1 2025 VEng VF

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