Mabion and Oddifact have submitted a request for a meeting with the FDA regarding the development of MabionCD20

Tel: +48 42 207 78 90 Email address: [email protected] www.mabion.eu 1 Konstantynów Łódzki, 12 August 2026 Press release MabionCD20 takes another important step towards the development of an innovative medicine - Mabion and Oddifact have submitted a request for a meeting with the FDA Mabion and Oddifact have submitted documentation to the US Food and Drug Administration (FDA) requesting a Type B Pre-IND consultation meeting regarding the development of MabionCD20 for the treatment of Immune Thrombocytopenia (ITP) This marks the significant milestone in the reactivated MabionCD20 project and represents a further step towards its development as a potential innovative therapy in the field of rare diseases ITP has been selected as the most promising indication for MabionCD20 at this stage of the project; the potential annual market value of anti -CD20 therapies for this indication in the US is estimated at approximately US$100 million The Pre -IND meeting with the FDA is intended to help validate the pre -clinical trial plan, the CMC strategy and clinical development, and to identify requirements prior to the potential commencement of clinical trials Mabion is drawing on its many years of experience in the development and characterisation of MabionCD20 to advance its own biological programme with global potential Mabion S.A. (WSE: MAB), a Polish biotechnology company specialising in the development and manufacture of biological products, has announced the achievement of significant milestone in the reactivation of the MabionCD20 project. Mabion, together with its strategic partner Oddifact SAS, has received confirmation that documentation covering a request for a Type B Pre -IND consultation meeting regarding the planned development of MabionCD20 for the treatment of immune thrombocytopenia (ITP) has been successfully submitted to the US Food and Drug Administration (FDA). The submission of the request to the FDA is a significant milestone in the implementation of the joint programme between Mabion and Oddifact, which aims to realise the potential of MabionCD20 and develop the project in the field of orphan diseases. The collaboration was initiated in May 2026, and its first phase was formally set out in an agreement signed in June 2026. MabionCD20, an anti -CD20 monoclonal antibody, is one of the assets being developed by Mabion as part of the Company’s strategy for 2025 –2030. The strategy envisages, alongside the further development of the CDMO business, the selective development of innov ative biological projects with higher added value, including projects based on the Company’s existing assets, scientific expertise and intellectual property. As part of the collaboration with Oddifact, an analysis was carried out of the potential applications of MabionCD20 in the field of orphan diseases. ITP has been identified as the most promising indication at this stage of the project. Immune thrombocytopenia is an autoimmune disorder in which the immune system destroys platelets, increasing the risk of bleeding. According to the Company’s estimates, the potential market value of therapy using an anti-CD20 monoclonal antibody for the treatment of ITP in the United States could be approximately USD 100 million per year. Tel: +48 42 207 78 90 Email address: [email protected] www.mabion.eu 2 Mabion has many years’ experience in the development, characterisation and manufacture of MabionCD20. Combining these capabilities with Oddifact’s expertise in identifying potential new uses for existing medicines has enabled the project to be reactivated and steered towards a selected indication in the field of rare diseases. The MabionCD20 project is an example of the Company’s strategy of selectively developing its own biological assets in collaboration with strategic partners, with a view to creating additional value beyond its core business. “Submitting an application for a Pre-IND meeting with the FDA is a tangible result of our efforts and an important step in the reactivation of MabionCD20. In the space of just a few months, we have taken the project from a reassessment of its potential to a clearly defined direction for clinical development in the US. This demonstrates that we are not merely talking about our strategy – we are consistently putting it into practice. We do what we say, and we talk about what we are actually doing. ITP has been selected as the most promising indication for MabionCD20 at this stage. Submitting the documentation to the FDA will mark the start of the next, very concrete phase – a dialogue with the US regulator, which will allow us to verify the development plan and prepare the project for the next stages. We still have a lot of work ahead of us, but MabionCD20 is no longer merely a reactivated asse t – today it is a programme under active development with a clearly defined path towards clinical trials,” - said Gregor Kawaletz, Chief Executive Officer of Mabion S.A. The further development of MabionCD20, including obtaining FDA approval for a meeting, the course of the consultation, the conduct of further pre -clinical and clinical work, and the possible future marketing authorisation of the product, will depend on the results of the work being carried out, the decisions of the relevant regulatory authorities, and the availability of suitable partners for the subsequent stages of the project. Contact for the media and individual investors Michał Wierzchowski +48 531 613 067 +48 22 440 14 40 [email protected] Mardoniusz Maćkowiak +48 605 959 539 +48 22 440 14 40 [email protected] Contact for institutional investors and analysts Piotr Owdziej +48 697 612 913 +48 22 440 14 40 [email protected] Information about Mabion SA Mabion S.A. (WSE: MAB) is a publicly listed Polish biopharmaceutical company, founded in 2007, which underwent a transformati on in 2023–2024 into a biologics -focused CDMO (Contract Development and Manufacturing Organisation) offering an integrated service portfolio. Mabion specialises in small to medium-sized projects at various stages of development – from the early-stage development of stable cell lines to commercial manufacturing. Mabion’s core competencies include monoclonal antibody development technologies, recombinant protein production (using mammalian and insect cell expression systems), advanced analytics, and the manufacture of drug substance. The company operates in compliance with globally recognised quality standards, including GMP, GCP and ISO. Mabion employs over 200 highly qualified professionals, including scientists, engineers and experts in quality, manufacturing and an alytical development for biologics. Headquartered in the centre of Europe, Mabion operates in Poland – an EU member state – providing access to highly regulated markets. The company’s mission is to be a trusted global partner for the development and manufacture of b iologic medicines. Mabion is a public company listed on the Warsaw Stock Exchange. For more information: www.mabion.eu

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