AB Science announces 2023 revenues and activity update

AB Science has released its financial results as of December 31, 2023, and provided an update on key developments during the period. 

Clinical Development Updates

Masitinib in ALS: AB Science continued its conditional marketing authorization applications for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) with both the European Medicines Agency (EMA) and Health Canada. The process initiated with the EMA in 2022 is ongoing, with an expected decision from the Committee for Medicinal Products for Human Use (CHMP) expected by mid-2024. Similarly, Health Canada is reassessing masitinib for ALS after initially issuing a Notice of Deficiency-Withdrawal.

AB8939 in Acute Myeloid Leukemia: In March 2023, AB Science reported a significant clinical response in a Phase I/II trial of AB8939, a microtubule destabilizer, used for treating a patient with refractory and relapsed acute myeloid leukemia (AML). The patient had experienced a dramatic reduction in bone marrow leukemia cells after treatment, and this positive response continued through subsequent treatment cycles, with no adverse toxicities reported.

New Program for Sickle Cell Disease: AB Science launched a new clinical development program for masitinib targeting sickle cell disease. This project, funded under the "Hospital-University Research in Health" initiative, aims to identify biomarkers and validate the efficacy of masitinib in treating both acute and chronic complications of sickle cell disease. This program will be funded with 9.2 million euros and includes a phase 2 clinical trial led by Assistance Publique-Hôpitaux de Paris (AP-HP).

Intellectual Property Enhancements

AB Science has strengthened its intellectual property portfolio, receiving new patents for masitinib in various indications:
- ALS: Patents granted in Japan and Canada until 2037.
- Mastocytosis: New European patent extending protection until 2036.
- Prostate Cancer: New European patent extending protection until 2042.

Financial Information

AB Science reported a consolidated operating loss of €13.4 million for 2023, an improvement from the €15.9 million loss in 2022. This 15.7% reduction in operating loss was achieved through a significant decrease in research and development expenses, which fell by 21.5%. The company's cash position stood at €6.1 million, supplemented by research tax credits to be received in 2024.

Net financial income increased to €3.4 million in 2023, compared to €2.3 million in 2022, predominantly due to the valuation of financial instruments. The net loss for the year was reduced by 26% to €10 million, down from €13.6 million in 2022.

Strategic and Corporate Actions

Clinical Development Strategy: AB Science is focusing on two main platforms: the late-stage clinical phase 3 platform for masitinib and the phase 1 microtubule platform. The company is prioritizing resources towards developing treatments for rare diseases and advancing the microtubule destabilizing agent AB8939.

Capital Augmentation: The Program d’Augmentation de Capital à Terme (PACT) with Alpha Blue Ocean was renewed, and Alpha Blue Ocean subscribed to a tranche of one million shares. This arrangement supports the company’s financial needs and helps maintain operational liquidity.

Financial Restructuring: AB Science has restructured its bond debt and Class C preference shares, converting convertible bonds into ordinary shares and repurchasing Class C preferred shares. This restructuring is part of a broader strategy to streamline the company’s financial obligations and improve its balance sheet.

Capital Increase: A successful capital increase raised €15 million through the issuance of new shares with attached warrants. This financial maneuver is intended to support ongoing and future clinical development activities.

European Investment Bank Loan: AB Science received €6 million as part of a €15 million loan from the European Investment Bank. This tranche has a five-year maturity and comes with the issuance of warrants.

Operational Changes

AB Science has implemented cost-reduction measures, including a redundancy plan, to align its organizational structure with its strategic focus. Additionally, new financial analysis coverage from DNA Finance and In Extenso Finance aims to enhance the company’s visibility and attract a broader investor base.

Court Rulings: The Paris Court of Appeal upheld the acquittal of CEO Alain Moussy on insider trading charges and reduced the financial penalty imposed on the company by €200,000.

Future Outlook

AB Science is committed to advancing its clinical programs and securing necessary licenses for masitinib. The company's strategic focus on rare diseases and innovative financing solutions aims to support its long-term growth and development goals.

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