MabionCD20 – FDA grants type B pre-IND meeting in just 14 days

Phone +48 42 207 78 90 Email address: [email protected] www.mabion.eu 1 Poland, Konstantynów Łódzki, 26th August 2026 Press release MabionCD20: FDA grants type B pre-IND meeting in just 14 days, advancing Mabion’s strategy to develop higher-value biological assets The U.S. FDA scheduled a Type B Pre -IND meeting (PIND 183961) for MabionCD20 within just 14 days of submission, setting the formal regulatory discussion for October 5, 2026 The program enters formal U.S. dialogue focused on persistent or chronic immune thrombocytopenia (ITP), addressing a target indication with an estimated annual anti -CD20 U.S. market value of $ 800 million (after further market examination) , within a broader global ITP treatment market currently valued at US$3.5–3.7 billion and projected to reach US$4.5–5.6 billion by the mid-2030s Advanced together with strategic partner Oddifact SAS, the project translates Mabion's 2025–2030 vision into action by building high -value biological assets alongside its established biopharmaceutical portfolio Pending regulatory green lights and successful clinical development, MabionCD20 is targeted to reach the global market in the 2030–2031 timeframe Mabion S.A. (WSE:MAB), a Polish biotechnology company specializing in the development and manufacture of biological products has announced that MabionCD20 (RTX-NP) has moved into formal U.S. regulatory dialogue for the development of a potential orphan treatment for patients with persistent or chronic immune thrombocytopenia, following the U.S. Food and Drug Administration's (FDA) decision to grant a Type B Pre-IND meeting scheduled for October 5, 2026. Importantly, the FDA scheduled the meeting within just 14 days of Mabion’s announcement of the submission of the meeting request, highlighting the rapid progress of the program toward formal regulatory dialogue in the United States. The FDA has formally opened PIND 183961 for MabionCD20. The upcoming meeting will focus on the regulatory and development pathway for MabionCD20 in adult patients with persistent or chronic primary immune thrombocytopenia (ITP) who have failed or relapsed after first-line therapy. Selected as the most promising lead indication, ITP represents an estimated $800 million annual addressable market for anti-CD20 therapies in the U.S., within a broader global ITP treatment market projected to reach $4.5–5.6 billion by the mid-2030s. MabionCD20 is a key example of the Company’s strategy to unlock additional value from its existing biological assets and intellectual property and selectively develop higher-value biological projects alongside its core CDMO business. The program is being advanced together with strategic partner Oddifact SAS, with the objective of developing MabionCD20 for an orphan indication where patients with persistent or chronic ITP may have limited treatment options following inadequate response or relapse after first-line therapy. For Mabion, this represents an important step in the execution of its 2025–2030 strategy, which combines the development of the Company’s CDMO business with the creation of higher -value biological projects based on Mabion’s assets and IP and developed together with strategic partners. “The FDA’s decision to schedule our Type B Pre-IND meeting within just 14 days is an important milestone for MabionCD20 and a strong demonstration of the pace at which we are advancing this program. MabionCD20 shows how we are executing Phone +48 42 207 78 90 Email address: [email protected] www.mabion.eu 2 our strategy in practice - taking an existing biological asset and unlocking its potential in a high -value orphan indication where patients continue to face significant treatment challenges. We are building Mabion beyond its traditional CDMO foundations, using our capabilities, assets and partnerships to create additional long-term value. The upcoming FDA meeting is an important next step in that journey” – said Gregor Kawaletz, Chief Executive Officer of Mabion S.A. “The FDA's decision to grant us a Type B pre -IND meeting for RTX -NP highlights the work accomplished by Oddifact and Mabion. ITP is an orphan indication with significant unmet medical need, and this milestone brings us a concrete step closer to a BLA submission and to delivering a specialized treatment option to patients in the U.S. and beyond” – added Pierre- Alexandre Teulié, CEO of Oddifact SAS. Scheduled for October 5, 2026, the FDA meeting will address key elements of the proposed development and regulatory pathway, including the potential BLA route and clinical development strategy. Ahead of this dialogue, the required background meeting package will be submitted by September 5, 2026. Subject to successful completion of subsequent development stages and the required regulatory approvals, MabionCD20 has the potential to reach the global market in the 2030 –2031 timeframe, supporting Mabion’s ambition to build a more diversified, higher-value biologics business. Mabion will provide further information following the FDA meeting in accordance with applicable disclosure requirements. Contact for 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 Polish biopharmaceutical company founded in 2007, which in 2023 –2024 underwent a transformation into a CDMO (Contract Development and Manufacturing Organisation) specialising in biologics and offering an integrated portfolio of services. Mabion specialises in small and medium-sized projects at various stages of development – from the early stages of developing stable cell lines through to commercial-scale production. Mabion’s key competencies include monoclonal antibody development technologies, the production of recombinant proteins (using expression systems in mammalian and insect cells), advanced analytics and active pharmaceutical ingredient (API) manufacturing. The company operates in accordance with internationally recognised quality standards, including GMP, GCP and ISO. Mabion employs over 200 highly qualified specialists, including scientists, engineers and experts in quality, manufacturing and analytical development of biological medicines. Based in the heart of Europe, Ma bion operates in Poland – an EU Member State – providing access to highly regulated markets. The company’s mission is to be a trusted global partner in the development and manufacture of biologics. Mabion is a public company listed on the Warsaw Stock Exch ange. More information: www.mabion.eu

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