MABION S.A.
Directors' Report for the year 2025
Konstantynów Łódzki, 27 April 2026
Table of Contents:
LETTER FROM THE PRESIDENT OF THE MANAGEMENT BOARD TO SHAREHOLDERS 1 SELECTED FINANCIAL DATA 3BASIC INFORMATION ABOUT THE COMPANY 4
Company Information 4
Branches and facilities 4
Company's management rules 4
Organisational or equity relationships 5
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COMPANY'S BUSINESS MODEL AND DEVELOPMENT STRATEGY 6
2.1 Company's business model 6
Strategy and development prospects for Mabion S.A. 7
Implementation of the strategy in the financial year 10
External and internal factors important for the Company's development 11
Assessment of the feasibility of investment plans 12
Key intangible assets 13
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COMPANY'S ENVIRONMENT 14
Market environment 14
Regulatory environment 15
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MAJOR EVENTS AND ACTIVITIES OF THE COMPANY 17
Products and services provided by the Company 17
Sales markets 19
Supply sources 19
Agreements entered into or terminated in the financial year of 2024 and after the balance-sheet date 20
Material agreements in the area of operations 20
Material agreements financing the Company's business 22
Sureties and guarantees 23
Transactions with related parties 23
Other major agreements 23
Significant factors and events affecting the Company's operations in the financial year 2025 and after the balance sheet date 23
Main domestic and foreign investments 24
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COMPANY'S FINANCIAL AND ASSETS POSITION 25
Accounting principles applied to the preparation of Financial Statements 25
Discussion of the Company's financial results for 2025 and factors and unusual events
having a material impact on the results achieved 25
Financial and non-financial performance indicators 26
Current and projected financial situation of the Company 26
Issues of securities 27
Financial instruments 27
Financial instruments used 27
Financial risk management objectives and methods 27
Dividend policy 28
Explanations of discrepancies between the actual financial results and the published forecasts 28
Assessment of financial resource management 28
- RISK AND THREAT FACTORS 29
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STATEMENT ON THE ON CORPORATE GOVERNANCE 38
Applied corporate principles 38
Corporate governance principles and recommendations not applied 38
Shares and shareholders of Mabion S.A. 40
The Company's share capital 40
Shareholders of the Company holding significant blocks of shares 41
Number of Company's shares held by managing and supervising persons 43
Employee share ownership schemes 43
Own shares 44
Holders of securities with special control rights 44
Restrictions on the exercise of voting rights 44
Restrictions on the transfer of ownership of securities 44
Agreements which may result in changes to the proportions of shares held by existing shareholders 44
The Management Board of Mabion S.A. 45
Composition of the Management Board and rules of appointment 45
Management Board's powers and activities in 2025 48
Remuneration of Management Board Members 48
Compensation agreements 48
Supervisory Board of Mabion S.A. 49
Composition of the Supervisory Board and rules for appointment 49
Powers of the Supervisory Board and description of its operations in 2025 51
Remuneration of the Supervisory Board Members 52
Committees of the Supervisory Board 52
Procedures related to the selection and services of an audit firm 53
General Meeting of Mabion S.A. 54
Operating principles of the General Meeting 54
Essential powers of the General Meeting 55
Rights of shareholders and the manner of their execution 55
General Meetings of the Company in 2025 57
Principles for amending the Company's Articles of Association 58
Internal control and risk management systems in relation to the financial reporting process 58
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SUPPLEMENTARY INFORMATION 60
Remuneration Policy 60
Liabilities arising from pensions and similar benefits 60
Information on judicial, administrative, and arbitration proceedings 60
Information on the audit firm 60
Information on employment 61
Key achievements in research and development 61
Environmental protection 61
Promotional and charitable activities 63
Investor relations and the Company's share price on the Warsaw Stock Exchange 64
8.10 The Company's share prices on the Warsaw Stock Exchange 65
Contact 66LETTER FROM THE PRESIDENT OF THE
MANAGEMENT BOARD TO SHAREHOLDERS
Our cash flow forecasts indicate that we will maintain financial liquidity until the end of 2026. From a financial perspective, 2025 was a challenging year, resulting in total net losses of PLN 62.6 million. Nevertheless, actual cash flow projections based on new deals completed by the current MB and planned capital increase are extending our liquidity covering the entire 2026. We have successfully secured nearly PLN 40 million in bridge financing through loans from Twiti Investments (PLN 18 million﴿, ACRX Investments (PLN 6 million﴿, and most recently, a strategic loan of up to EUR 3.1 million from the Japanese company CBC Co., Ltd. For details, please look into the specific financial figures attached to the report.
Gregor Kawaletz Prezes Zarządu Mabion S.A.
Dear Shareholders and Investors,
I hereby present to you the financial report for 2025, which was a period of profound transformation for Mabion S.A. and a time of confronting unprecedented market challenges. To fully understand the Company's current situation, it is necessary to refer to the events of recent years, which have permanently reshaped the global biotechnology landscape.
The World Health Organization declared COVID-19 a Public Health Emergency of International Concern in January 2020 and a pandemic in March 2020, with the emergency officially ending in May 2023. Following a decade of strong growth after 2010, the biotech sector experienced a sharp reversal as vaccine manufacturing demand - accelerated during COVID-19 - collapsed. The global vaccine market declined from over $2 billion in 2024 to nearly zero in 2025. This unprecedented shift impacted numerous biotech companies and CDMOs worldwide and was the primary driver of Mabion's downturn, which began in late 2024 and continued through 2025. Despite increased commercial efforts, the former Management Board was unable to anticipate or mitigate the scale of this market collapse, leaving Mabion exposed - similar to many industry peers.
In response, the Supervisory Board acted decisively, appointing a new CEO and Management Board, fully operational since October 2025. Importantly, despite the COVID-19 market cliff, Mabion's industrial, scientific, and technological foundations remain strong.
"It´s known and reported in the special market publishing papers that many of the largest and most influential venture investors remain flush with cash, while the progress in genetic medicine, oncology & autoimmune diseases research promises new kinds of treatments in the future. As well, globally Venture Funding levels have stabilized somewhat after a multiyear decline"1.
We have defined a new strategy focused on pragmatic longterm growth. The new Member Board, in collaboration with the Mabion management team, has reformulated the New Strategic Plan 2025-2030, that has been already published on November 17th, 2025 and contains tree major pillars Mabion will focus in future about. CDMO will remain a part of Mabion, but Co-Development of biosimilars is very much requested on the Market, so Mabion will be starting still in 2026 with few molecules and partners. In addition to that the long-term strategy to go back to the innovators market needs to be accelerated as there are great opportunities involving Mabion's know-how. Will impact Mabion's organic growth, but it may also consider in-organic growth, if the assets will show foreseeable success. In that innovation section we are in negotiations to restart CD20 project under new rules and new indications. The outcome will be reported still in this year.
The Biotech industry is very dynamic in terms of innovation considering new technology solutions as well as implementation of AI to become more efficient and cost effective. In both fields Mabion is very much engaged. for mAbs is very promising in relation to reduce massively the costs of goods, which will lead to "Democratisation of Biologs" and Mabion is very much focusing on on this project. While AI in the Biotech industry will allow to reduce the time in development as it allows to analyse data much faster and show predicted outcome. In both areas Mabion is in advanced discussions. Those activities will allow Mabion to extend the addressable market.
New Mission and Vision redefined, and a much more pragmatic long-range plan has been formulated. We envision completing a financial break-even point before the end of 2026 and following a compounded annual revenue growth of at least a plus 50% more on sales vs the last five-year average 2021-2025 by 2030. After two years of compromised results, 2024 and 2025. The target revenue is expected to exceed 100 PLN million. This would represent a year compounded growth of 13,5% over the break -even amount fixed in 70 PLN million in 2026. The first quarter of
1 Emerging biotech. Trendline. BIOPHARMADIVE. Ben Fidler, December 2025
2026 has already demonstrated the effectiveness of our new direction. We have secured analytical assignments from existing clients worth over PLN 7.5 million.
Our human capital remains a core strength supporting operational excellence. To voice and value the excellent scientific and technological savvy of the entire Mabion team with demonstrated skills and capabilities in the successful technological transfer, validation, and manufacturing of the four COVID-19 proteins made in exclusivity for Novavax during the period 2021-2024 with extreme Quality and outstanding Customer Service Levels. Based on their recurrent qualified performance, both companies have extended all analytical and stability testing till the end of 2026.
We have fundamentally reengineered our business development function. A primordial and exclusive initial intent has been to redesign the entire Business Development function. Added four new FTE´s and created an Advisory Board composed of experienced and talented five senior executives, with experience working for industry leaders such as Pfizer, Amgen, and Sartorius, covering critical regulatory, operations and commercial areas, and extended experience in each specific field. They have a very diverse origin and are collectively serving us, helping to drive business development efforts and gaining potential new clients. The rewarding model is based on factual business achievements. We have modified the plan related to the Mabion II project, to reflect current priorities. We have put plans to build Mabion II, which was to focus on medicinal products, on hold for the next few years. More realistically, we decided to focus on Drug Substances exclusively, expanding our existing services related to monoclonal antibodies to include capabilities such as antibody-drug conjugation and bispecific antibodies as well as Advanced Therapy Medicinal Products ATMPs, acting as a CDMO and a partner in co-development.
We are strengthening our focus on intellectual property protection. Conjugating CDMO activities with New Molecular Entities Co-Development has forced us to develop exclusive processes to respect the Customer's IP & protect it from non-desired releases of knowledge.
The MabionCD20 development has marked a big milestone for the organization. Now we are in advanced discussion with partners about a new market access of Mabion CD20 and we see good chance to proceed fast with that innovative approach.
Extending our portfolio coverage, as already described, we are, as well, driving Bispecific and Drug Conjugated Antibodies with immersion in the veterinary arena where we consider exists a great important niche of new business. Enhancing competitiveness by scientific excellence is critical to winning new business globally. To have the possibility of winning new business, competing properly in a more global arena, you have to be capable of offering an optimal service value and pricing. This is a key factor we are focusing on and optimizing, making efforts to enroll the pioneers who have commenced to offer the called Continuous Manufacturing. This technology has extremely optimal deliverables vs conventional manufacturing with discrete processes, the upstream and downstream ones. This new
methodology and operating system allow much bigger productivity, expressing it as one titter increase of much of the 80% vs conventional processes. As a result, the cost per gram of bio product can be reduced in the order of magnitude of 20 to 25% vs conventional current costs/prices being offered to clients. In Mabion's world we call it DEMOCRATISATION OF BIOLOGICS reducing the costs for the healthcare insurances and patients.
This is to be developed in collaboration with the main leaders in the industrial biotech market segment. Mabion has already set up initial agreements to support this development. We are committed to delivering optimal customer service and operational excellence. Service to clients is the basic pillar on which we build our Customer Loyalty and Gentle Partnership. We are committed to continuing to stress the Operational Excellence that we want to base on basic lean processes, enhancing Operations Quality, Yield titter, and overall process throughput continuously.
We are advancing talent culture and organizational competitiveness. To complete our focus on Excellence, we have to mention and describe the Talent Culture Development and the Organizational Competitiveness.
The aim is to foster a continuous Innovation attitude to embrace the use of Artificial Intelligence (AI﴿ tools to optimize and simplify critical processes and support, simultaneously, the Heart Decision Leadership with the Fast-Thinking Model (Intuition promotion﴿. The AI initiative is in discussion with GLOBAL established partners to ensure best results. We want to support a purpose-driven corporate culture rooted in integrity and impact.
In conclusion, we are navigating adversity with a clear plan and renewed strength.
There is one old saying: "Adversity doesn´t build character, it reveals it". We are not disclosing anything not already known, saying that the abrupt termination of the COVID-19 pandemic has taken a dozen companies into critical difficulties. Many of them have disappeared. Not sure they deserved this closing/end, but in Mabion, we are sure about our reshaping and revamping of all activities and improving our critical competitiveness to place our organization as a preferred Mid-Sized BIOTECH for a global market. All because of the great service attitude, skills, and capabilities of our genuine employees. We well know that the value is in serving others, and this is fostering all our Company Clients' Service Attitude. I am personally committed to this journey, having recently invested nearly PLN 400,000 to acquire approximately 50,000 Company shares, signaling my full confidence in our fundamental value.
Thanks to all the company stakeholders who are making us a great place to work.
Not needed, but saying that, I am profoundly grateful to have the opportunity to lead this Company and our exceptional employees.
Sincerely, Gregor Kawaletz CEO Mabion S.A.
SELECTED FINANCIAL DATA
Table 1. Selected financial data of Mabion S.A. for 2025
Selected financial data of Mabion S.A. in PLN thousand in EUR thousand 2025 2024 2025 2024Przychody netto ze sprzedaży | 15 757 | 69 019 | 3 719 | 16 035 |
Zysk (strata﴿ z działalności operacyjnej | (59 594﴿ | (7 185﴿ | (14 065﴿ | (1 669﴿ |
Zysk (strata﴿ przed opodatkowaniem | (62 614﴿ | (1 649﴿ | (14 777﴿ | (383﴿ |
Zysk (strata﴿ netto | (62 614﴿ | (6 334﴿ | (14 777﴿ | (1 472﴿ |
Przepływy pieniężne netto z działalności operacyjnej | (41 590﴿ | 39 863 | (9 815﴿ | 9 261 |
Przepływy pieniężne netto z działalności inwestycyjnej | (795﴿ | (12 287﴿ | (188﴿ | (2 855﴿ |
Przepływy pieniężne netto z działalności finansowej | 10 309 | (36 945﴿ | 2 433 | (8 583﴿ |
Przepływy pieniężne netto razem | (32 076﴿ | (9 369﴿ | (7 570﴿ | (2 177﴿ |
31 December 2025 31 December 2024 31 December 2025 31 December 2024 | ||||
Aktywa razem | 110 433 | 159 472 | 26 128 | 37 321 |
- w tym Środki pieniężne i ich ekwiwalenty | 6 372 | 38 448 | 1 508 | 8 998 |
Zobowiązania i rezerwy na zobowiązania | 61 605 | 48 031 | 14 575 | 11 241 |
Zobowiązania długoterminowe | 17 751 | 8 898 | 4 200 | 2 082 |
Zobowiązania krótkoterminowe | 43 854 | 39 133 | 10 375 | 9 158 |
Kapitał własny | 48 828 | 111 442 | 11 552 | 26 080 |
Kapitał zakładowy | 1 616 | 1 616 | 382 | 378 |
Liczba akcji (w szt.﴿ | 16 162 326 | 16 162 326 | 16 162 326 | 16 162 326 |
Średnioważona liczba akcji (w szt.﴿ | 16 162 326 | 16 162 326 | 16 162 326 | 16 162 326 |
Zysk (strata﴿ netto na jedną akcję zwykłą | (3,87﴿ | (0,39﴿ | (0,91﴿ | (0,09﴿ |
Wartość księgowa na jedną akcję | 3,02 | 9,87 | 0,71 | 2,31 |
Zadeklarowana lub wypłacona dywidenda na jedną akcję | - | - | - | - |
Individual balance sheet items have been converted into euros at the average exchange rate applicable on the relevant balance sheet date, as announced for the euro by the National Bank of Poland (31 December 2025 - PLN 4.2267, 31 December 2024 - PLN 4.2730﴿. Individual items of the
profit and loss account and the cash flow statement have been converted into euros at a rate representing the arithmetic mean of the average exchange rates announced by the National Bank of Poland for the euro, applicable on the last day of each month of the financial year (2025
- PLN 4.2372, 2024 - PLN 4.3042﴿.
BASIC INFORMATION ABOUT THE COMPANY
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Company Information
Mabion S.A. (hereinafter "Mabion" or "the Company"﴿ is a Polish biopharmaceutical company providing contract services in the development, analysis and manufacture of biological medicines (Contract Development and Manufacturing Organisation, "CDMO"﴿.
Mabion was established on 30 May 2007 as a limited liability company with its registered office in Kutno. The Company's legal form changed on 29 October 2009 following its conversion into a public limited company. In 2016, the Company's registered office was moved to Konstantynów Łódzki.
Mabion S.A. shares have been listed on the Warsaw Stock Exchange since 2010.
Registration and contact details of the CompanyName (company name﴿: Mabion Spółka Akcyjna Registered office: Konstantynów Łódzki
Address: 60 Gen. Mariana Langiewicza Street,
95-050 Konstantynów Łódzki KRS (National Court Register﴿ number0000340462
District Court for Łódź - Śródmieście in Łódź,
20th Commercial Division
of the National Court Register Tax Identification Number 7752561383
REGON 100343056
Contact telephone number: Tel. (+48 42﴿ 207 78 90 Email address: info@mabion.eu
Website address: https://www.mabion.eu
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Branches and facilities
The Company does not have separate branches within the meaning of the Accounting Act of 29 September 1994 ("Accounting Act"﴿.
The Company's key assets include the resources and expertise concentrated within two of its facilities:
The Research and Development Centre for Biotechnological Medicinal Products in Łódź at 17 Fabryczna Street - dedicated to work related to the provision of analytical and development services for biological products, and
The Medical Biotechnology Science and Industry Complex in Konstantynów Łódzki at 60 Gen. Mariana Langiewicza Street, which is also the Company's registered office. It fulfils three main functions: R&D, quality control and manufacturing. It is one of the most modern biotechnology drug production facilities in Poland. In recent years, the facility has undergone modernisation and been equipped with new machinery, providing new technological capabilities and increased
production capacity, thereby strengthening the Company's position as a CDMO. Since 2023, the plant has had diversified bioreactor technologies in its production area. In addition to orbital bioreactor technology (mixing via the orbital movement of the entire bioreactor﴿, new bioreactors featuring classic cell culture mixing technology (mixing using a stirrer placed inside the culture bag﴿. Both types of bioreactors are based on the use of sterile, single-use materials ( ﴿. Drug production at the facility is carried out in accordance with Good Manufacturing Practice (GMP﴿, under the Manufacture and Importation Authorisation (MIA﴿ issued by the Main Pharmaceutical Inspectorate (GIF﴿.
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Company's management rules
The Company operates in accordance with generally applicable regulations, including the Commercial Companies Code, and in accordance with the provisions of the Company's Articles of Association. The governing bodies of the Company are: the General Meeting, the Supervisory Board and the Management Board. The Management Board is responsible for conducting the Company's affairs, representing it externally and managing the Company's assets. The Management Board's powers include all matters not reserved for the General Meeting and the Supervisory Board. The Management Board operates in accordance with the Company's Articles of Association and the Management Board Regulations, which are adopted by the Management Board and subsequently approved by the Company's Supervisory Board.
In 2025, changes took place in the fundamental principles of the Company's management, linked to changes in the composition of the Management Board resulting in changes to the areas of responsibility assigned to individual members of the Company's Management Board.
On 5 September 2025, the Supervisory Board adopted a resolution on the dismissal of Mr Krzysztof Kaczmarczyk from the position of Chairman of the Management Board and from the Management Board of the Company, and on the appointment of Mr Detlef Behrens and Mr Joaquín Santos Benito to the Management Board and the entrusting of the functions of Management Board Members to them. At the same time, on the same day, Mr Grzegorz Grabowicz tendered his resignation from the position of Member of the Company's Management Board, with effect from 5 September 2025. Subsequently, on 12 and 19 September 2025, Ms Julita Balcerek and Mr Adam Pietruszkiewicz respectively tendered their resignations with immediate effect from their positions as Members of the Company's Management Board. Ms Julita Balcerek remained with the Company, taking up the position of Chief Operating Officer.
On 24 September 2025, the Company's Supervisory Board adopted a resolution appointing Mr Gregor Kawaletz to the Company's Management Board for the second joint term of office with effect from 1 October 2025 and entrusting him with the role of Chairman of the Management Board.
The appointed Management Board has the authority to implement the adopted strategy and further develop the Company.
The current division of key areas, tasks and responsibilities within the Company at Management Board level is as follows:
Gregor Kawaletz - Chairman of the Management Board. He represents the Company externally and oversees its overall operations. He is primarily responsible for developing and implementing the Company's business strategy. He is responsible for securing strategic business partners, finance, oversight of regulatory affairs, quality management, HR, legal affairs, administration, IR, ESG and IT.
Detlef Behrens - Member of the Management Board for Business Affairs. Primarily responsible for business
development and acquiring new clients. He is responsible for leading strategic projects related to international expansion, building and managing relationships with key clients and partners, and identifying and capitalising on new market opportunities.
Joaquín Santos Benito - Member of the Management Board for Transformation. Primarily responsible for operational management, optimising key business processes, leading transformation programmes and continuous improvement initiatives. He is responsible for shaping the long-term vision for development and organisational culture, and ensuring sustained performance and high engagement among employees. As at the date of publication of this Report, the Company's organisational chart is as follows:
Graphic 1. Organizational structure Mabion S.A.
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Organisational or equity relationships
Mabion S.A. does not hold any shares in other entities. Nor are there any other circumstances that might lead to the conclusion that the Company is a parent company within the meaning of Article 4(1﴿(4﴿ of the Commercial Companies Code ("CCC"﴿.
The Company does not belong, either directly or indirectly, to another entity - to the best of the Company's knowledge, there are no entities that would meet the criteria for the definition of a parent company in relation to the Company in accordance with Article 4(14﴿ of the Act on Public Offering and Conditions
Governing the Introduction of Financial Instruments to Organised Trading and on Public Companies ("Public Offering Act"﴿ and the definition of a parent company in relation to the Company in accordance with Article 4 § 1(4﴿ of the CCA. Furthermore, to the best of the Company's knowledge, the shareholders and members of the Company's governing bodies are not bound by an agreement as referred to in Article 87(1﴿(5﴿ and Article 87(4﴿ of the Public Offering Act. The Company's significant shareholders do not hold any voting rights other than those arising from the shares they hold.
To the best of the Company's Management Board's knowledge, there are also no other organisational or capital links between the Company and other entities.
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Company Information
COMPANY'S BUSINESS MODEL AND DEVELOPMENT STRATEGY
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Company's business model
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CDMO
Mabion S.A. is a manufacturing and service company and, as a CDMO, offers an integrated service for the development
and manufacture of biological products, including monoclonal antibodies, for the global biopharmaceutical market. The Company's business model is based on providing services for small and medium-sized projects, ranging from the establishment of stable cell lines and process and analytical development to commercial manufacturing in accordance with applicable and area-specific GMP standards. As at the date of publication of this Report, the Company is ready to provide services in the following areas:
1﴿ process development,
2﴿ active substance (DS﴿ manufacturing - up to the clinical and commercial stages,
3﴿ finished product (FP﴿ manufacturing in partnership - up to the clinical and commercial stages
4﴿ analysis of medicinal products (DS and DP﴿ as well as batch release and stability testing. Ultimately, in line with the Company's Strategy for 2025-2030, the following revenue streams are anticipated within the CDMO business:
Graphic 2. A well-developed portfolio of services for a wide range of biological products
A key element of the Company's business model is the integrated nature of the services offered, which enables clients to utilise either a single service or a range of services, with the option of parallel delivery-either by the Company itself or by one of its industry partners-all of which are comprehensively supervised and managed by Mabion. The convenience for the client of not having to divide project management responsibilities not only offers cost and time benefits but also minimises risks.
Mabion can offer clients both a service package and, on request, develop a medicinal product from the stage of establishing a stable cell line, utilising all the above streams (process development,
analytical tool development, manufacturing﴿, as well as respond to the needs of clients who wish to limit themselves to selected services. Delivering the full scope of the offering within the adopted model is possible through collaboration with service providers in the form of industry-specific business partnerships, which are based on the provision of complementary services to clients. The comprehensiveness of the offering, combined with reaching a wider client base, is a natural benefit for both parties to the partnership. Furthermore, this model allows the Company not only to better position itself in the CDMO market, but also to focus on a range of services that best utilises production capacity and enables the achievement of maximum revenue.
The Company operates on the basis of an outsourcing model focused on long-term cooperation with partners, offering a flexible approach to biomanufacturing projects, process scalability and the integration of regulatory and quality control services.
Thanks to its modern infrastructure and investments in innovative biomanufacturing technologies, the Company ensures operational efficiency, cost predictability and accelerated time-to-market for biological products.
Among its strengths and capabilities, the Company identifies, above all, scientific expertise in the development and manufacture of biological medicines. Its technological, equipment and systems infrastructure enables the Company to undertake the most commercially attractive projects for the development of biosimilars (mAb﴿ and ADCs (Antibody-Drug Conjugates﴿. One of the Company's competitive advantages is also its strategic location in Central and Eastern Europe, which allows for attractive pricing of services delivered in accordance with recognised standards and supported by a thriving European network of suppliers.
A model integrating the highest quality standards with the optimisation of production processes makes Mabion an attractive partner for global biopharmaceutical companies seeking high-class biotechnological solutions - within the framework of a comprehensive chain of processes related to the manufacture of biological medicinal products.
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CO-Development of Biosimilars
We are addressing a critical market need with this strategic pillar, as many clients continue to face challenges in financing biosimilar development even when using tailored approaches. In this context, Mabion positions itself as a reliable and committed partner. These projects are structured around a shared framework of risk, cost, and profit. Through this model, Mabion not only supports development but also becomes a co-owner of the products it manufactures for its partners, creating aligned incentives and long-term value.
- Innovation
In November 2025, Mabion defined its strategy, including a focus on innovative products leveraging its scientific excellence. This pillar was originally positioned as a long-term initiative. However, given the increasing dynamism of the market, we now see a significant opportunity to accelerate this segment of the business.
We plan to onboard advanced therapy medicinal products (ATMPs﴿ across various preclinical and clinical stages. While the initial modalities will align with our strategic focus-including antibody-drug conjugates (ADCs﴿-we remain flexible and open to additional high-potential opportunities as they emerge. In this area, Mabion will primarily engage in Co-development partnerships. At the same time, we are actively evaluating inorganic growth opportunities to further strengthen our capabilities and support our ambition of establishing a leading Central European Center of Innovation.
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CDMO
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Strategy and development prospects for Mabion S.A.
The 2025 financial year was a period of exceptionally intensive work and analysis for the Company regarding its future and its vision for the best possible directions for the development of its business. In recent years, the Company has undergone a business model transformation from a product-based model focused on the development of its own biotechnology projects to a production and service model based on fulfilling client orders in the CDMO sector.
Mabion S.A.'s Strategy for 2023-2027The Company began the 2025 financial year by continuing to implement the objectives adopted in April 2023 in the Mabion
S.A. Strategy for 2023-2027 (see the Company's current report No. 7/2023 of 26 April 2023﴿. These objectives focused on completing the Company's transformation into a fully integrated CDMO, building recognition within the CDMO services sector, modernising the Company's existing plant and laboratories, achieving business and technologic , and implementing the investment in the new Mabion II plant. From a financial perspective, the Strategy for 2023-2027 envisaged Mabion as a self-financing entity in terms of its day-to-day operations and securing funding for the necessary investments.
The Company's strategic objectives for 2023-2027 were consistently implemented by the Company; however, the experience gained during sales and marketing activities aimed at building Mabion's recognition within the industry and acquiring new clients and orders led the Company to review its adopted objectives.
Update of the 2023-2027 Strategic Plan - Outlook for 2025-2030On 23 April 2025, following the analyses carried out, the Company adopted the Mabion S.A. Strategy for 2025-2030 (see the Company's current report No. 7/2025 of 23 April 2025﴿.
This strategy provided for the continuation of the objectives adopted in the previous strategy and, building on the Company's existing operations as a CDMO.
The objective for 2025 was to convert existing business relationships into contracts, secure industry partners, increase brand recognition and secure funding for the Company's further development. Detailed information on the above objectives and the actions taken to achieve them in 2025 is set out in section 2.3 of this Report.
Looking further ahead, the objective for 2026-2028 was the effective execution of contracts, a focus on high-margin services, attractive and repeatable financial results, and the completion of the first phase of the Mabion II facility construction, with the final decision to commence this investment being contingent on business factors, including securing financing, the pace of the Company's growth as a CDMO, and the Company's financial results. Subsequently, after 2029, the strategic objectives envisaged the launch of the first module of Mabion II, the
expansion of the target customer base, and the achievement of a return on invested capital and a total return on investment at levels above the market benchmark.
Mabion S.A.'s Strategy for 2025-2030 (current 2025-2030 Strategy﴿In September 2025, significant changes took place in the composition of the Company's Management Board. The Company's Management Board, in its new composition, carried out a comprehensive review of the previously adopted strategic assumptions and, as a result, on 14 November 2025, adopted a resolution on the adoption of the new Strategy of Mabion S.A. for 2025-2030 (see the Company's current report No. 33/2025 of 17 November 2025﴿. On 17 November 2025, the Supervisory Board gave a positive opinion on the adopted strategy, thereby formally approving it for implementation.
The strategy for 2025-2030 focuses entirely on drug substances (DS﴿ and the expansion of operations to include partnerships in joint development and continuous manufacturing - responding to global trends as well as customer demand for value-added services. The development plan also envisages entering segments with the highest growth potential.
The aim of the Strategy is to strengthen the Company's position as a flexible, technologically advanced CDMO and to secure new service-based contracts for the development of biosimilars in collaboration with partners, as well as new innovative products based on its own intellectual property. Co-DEVELOPMENT with partners and INNOVATION.
MissionMabion accelerates the development and production of life-changing biological medicines, delivering world-class quality and service from its facility in Poland. The Company's aim is to bring life-changing medicines to market quickly and safely - based on science, technology and partnerships.
VisionThe Company's aim is to become the most flexible and technologically advanced CDMO for large-molecule biologics in Europe - synonymous with quality, scientific excellence, supply reliability and lasting customer relationships.
Between 2025 and 2030, the Company plans to offer its services as a CDMO, including Co-development models, and to develop innovative projects based on its intellectual property. In the Company's view, a diversified offering rooted in creativity and innovation will be a critical factor enhancing Mabion's competitiveness, as value-added collaboration and an expanded range of services will become increasingly important to the market, but always with a reference to a realistic pragmatism that Mabion's Management Board consider the base ground of all the synergies they are trying to develop. The Company's scientific development and anticipation of market needs will be ensured through the establishment of an Advisory Board, comprising market experts and representatives from the scientific community. The Advisory Board will contribute additional specialist knowledge, and the implementation of lean management solutions in operational management will enable an increase in plant efficiency. Strengthening the Mabion brand's recognition in the market will be one of the key aspects necessary to realise Mabion's vision as a provider of reliable CDMO services and an innovator in the scientific field.
Strategic pillars for realising the visionThe 2025-2030 Strategy defines three strategic pillars for the realisation of the Company's vision:
Graphic 3. Strategic pillars for realising the vision
Mabion will focus on projects involving cell line development, the development and manufacture of drug substances (DS﴿, and the development of analytical methods. The market segments that the Company identifies as of interest for its projects are biosimilars, antibody-drug conjugates (ADCs﴿, bispecific/innovative drugs, and highly potent/precision-handling biologics, mainly used in human therapy.
The Company also plans to revive the MabionCD20 project, albeit in a new format involving the use of CD20 as part of an innovative drug.
The company will pursue both early-stage development projects and commercial projects. Geographically, Mabion will expand its operations into rapidly growing markets, including the MENA region (Middle East and North Africa﴿ and Asia. However, US will play still an important role.
Strategic objectivesThe following timeframes and priorities have been adopted for the various types of projects:
Short-term objectives
Implementation of projects in the biosimilars segment (as a CDMO﴿ and ADC segment (as a CDMO in partnership﴿ -strategic projects;
The MabionCD20 project (as an innovative medicine﴿;
Implementation of projects in the veterinary biologics and vaccines segment - projects of complementary/tactical significance;
Establishment of the Mabion Advisory Board;
Activities aimed at strengthening the Mabion brand's recognition (trade fairs, networking﴿;
Innovation including inorganic growth.
Medium-term objectives
Implementation of projects in the biosimilars segment (as a CDMO﴿, ADC (as a Co-developer in partnership﴿ and projects related to bispecific medicines - strategic projects;
Implementation of projects in the segment of highly potent/precision-handling biologics and vaccines - projects of complementary/tactical significance.
Long-term objectives
Delivery of projects in the biosimilars segment (as a CDMO﴿ and independently managed projects in the ADC segment -strategic projects;
Implementation of projects in the segment of highly potent/precision-handling biologics and vaccines - projects of complementary/tactical significance.
Table 2. Key Performance Indicators (KPIs﴿ for 2030
KPI 2026 i okresy referencyjne 2030
Financial Total revenue Reference period: 2021-2025 ave. PLN >70m*
ca. PLN 100m
EBITDA margin 0%
>30%
Operational Dostawy OTIF 93%
Minimum 98%
Project onboarding lead time 12 weeks
Reduced by 5%
OEE 48%
Increased by 20%
Customer service Client satisfaction 93%
Great improvment
RFTR 94%
Significant improvment
Voluntary Turnover 9,4%*
<5%
* Approximate revenues excluding material revenues
** Data calculated based on the number of voluntary exits divided by average number of employees from 2023 to September 30, 2025
Financial planThe implementation of the 2025-2030 Strategy is to be financed through equity, cash flow, as well as debt instruments and EU grants. In line with the adopted assumptions, the implementation of the 2025-2030 Strategy is expected to result in sales revenue in 2030 that is 40% higher than the average for 2021-2025 (the average for 2021-2025 is almost PLN 70 million per year﴿, with an EBITDA margin (EBITDA - operating profit adjusted for depreciation and amortisation﴿ of over 30%.
Mabion expects to reach the EBITDA break-even point by the end of 2026.
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Implementation of the strategy in the financial year
The following strategic objectives have been adopted for 2025:
Converting existing business relationships into contracts and will push innovation. Mabion will leverage its cost-based competitive advantage, flexible terms of cooperation and speed of operation to effectively acquire clients. The Company targets a strictly defined group of clients (small and medium-sized biotechnology firms﴿ and a preferred project value range (small and medium-sized projects worth PLN 10-50 million﴿ to gain partners for Co-development of biosimilars and innovative modalities as well as projects for the CDMO business. It offers flexible terms of cooperation at every stage of project implementation. Mabion's offering has a big portion of market needs, with its scientific excellence. In addition it has a price advantage over competing offers from firms in Western Europe or the USA. In 2025, the Company is increasing its tender activity and has the capacity to prepare
tenders quickly. The expected outcome of these efforts will be the signing of contracts with clients in Q2 2026.
Acquiring industry business partners for Co-development of biosimilars. Cooperation with a select group of experienced partners offering complementary services enhances the effectiveness, competitiveness and comprehensiveness of Mabion's offering. This type of cooperation enables to provide comprehensive services in the field of Co-development, registration and commercialization of the mAbs, ADCs and other ATMPs. As a result, Mabion's production capacity will be utilised to the full. These activities should translate into an expansion of the contract portfolio and customer base, thereby maximising profits.
Increasing brand recognition. Precision in positioning and selectivity in action. The company will continue its presence at industry events using its industry network, limiting itself to the key and most promising ones. Conducting intensive marketing activities using webinars or industry publications will allow us to reach a wider group of potential customers. As a result, a higher number of enquiries from customers and an increase in visits to Mabion's headquarters are expected.
Securing financing for further development. Business expansion and the Company's further development require additional external financing. All financing options that would be beneficial to the Company are being considered, including, amongst others, raising debt financing, securing an industry or financial investor, as well as increasing capital through a share issue. Securing financing is an essential measure planned for 2025, enabling the Company's further development planned for the years 2025-2030.
In 2025, the Company implemented the objectives of its development strategy by undertaking the following actions:
intensive sales activities aimed at securing new contracts and the continued implementation of measures to position the Company as a partner understanging market needs including Co-development of biologics, by expanding the range of competencies and services;
activities aimed at developing the order portfolio -efforts initiated to find partners for the Co-development of biological products;
strategic partnerships with industry leaders, espacially the continuation of strategic cooperation with the first partner -Sartorius Stedim Cellca GmbH, establishing a narrow collaboration in the innovation field - as well as establishing new partnerships, including with Celon and Syvento;
updating Mabion's service offering based on market signals, feedback from existing customers, the organisation's know-how, and available infrastructure and human resources, in order to align the offering as closely as possible with market expectations and enhance its competitiveness;
implementing a computerised LIMS (Laboratory Information Management System﴿, which enables the management of processes and data in the Quality Control laboratory, helps to automate tasks, ensure data integrity, streamline processes and increase work efficiency, which is appreciated by CDMO clients;
submitting tenders and conducting commercial and technical discussions as part of building the Company's order portfolio;
intensive marketing activities to increase brand recognition and awareness of Mabion's services using own industry network, including webinars available on industry portals, and promotional campaigns on LinkedIn and updating the Company's website;
participation in interviews for industry media, the creation of publications and video materials of a scientific and promotional nature, as well as the promotion of Mabion's activities through a competition supporting biotech companies' projects within the scope of the Company's services;
measures aimed at securing financing for the Company (debt financing, financing through a share issue, or attracting an industry or financial investor to provide additional funding to the Company﴿. Given the complexity of the above processes and the time they would take, the Company requested bridge financing in the form of a loan from its shareholders. As a result of the actions taken, on 24 October 2025 the Company entered into a Term Sheet with Twiti Investments Ltd., a loan agreement under which Twiti Investments granted the Company a loan of PLN 18 million for a period of two years.
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External and internal factors important for the Company's development
Information on agreements concluded in the areas of operations and financing is presented in section 4.4 of this Report. Other significant factors and events affecting the Company's future development are set out below.
Regulatory environmentThe regulatory environment for biopharmaceutical service companies (CDMOs﴿ is similar to that for manufacturers operating in the pharmaceutical industry and reflects the high standards and strict quality requirements applicable to the entire biopharmaceutical sector. These requirements are defined by regulatory agencies such as the FDA (Food and Drug Administration﴿, the EMA (European Medicines Agency﴿ and national authorities -detailed information can be found in section 3.2. Regulatory environment.
Ability to fulfil orders within the scope expected by clients (operational, quality﴿Thanks to the implementation of the new strategy, as well asits own projects in the period preceding the transition to a Biotech company with CDMO activitites and its ongoing activities related to the development of a platform-based approach to the optimisation of processes and analytical methods, the Company possesses the knowledge, experience, skills and equipment necessary to fulfil market needs within the scope expected by clients. The Research and Development Department has the technical and scientific facilities to carry out client projects from the stage of a stable cell line producing protein through to the development and optimisation of the manufacturing process for biological products on a laboratory scale and process characterisation, alongside a detailed analysis of the quality of the product obtained. At the same time, it has a wide range of advanced analytical methods at its disposal, the basic principles of which can be applied to subsequent products analysed as part of client projects. The company also has compatible equipment for conducting manufacturing processes on both a laboratory and industrial scale, enabling the rapid and efficient scaling up of processes developed on a laboratory scale to a manufacturing scale and their regular operation in accordance with GMP standards. The Manufacturing Department has the technical and scientific facilities to carry out client projects from the generation of master cell banks through to the manufacture of the active substance and the finished product. The compatibility of equipment between the Research and Development and Quality Control Departments, in turn, enables the transfer of optimised analytical methods developed at the early stages of client projects to adapt them for use in process control and product release procedures.
The use of validated analytical methods is crucial for controlling the quality parameters of manufactured products. The Quality Control Department possesses the knowledge and experience necessary to assist in adapting the validation or transfer of the client's analytical methods to the current requirements of the International Council for Harmonisation Good Clinical Practice
(ICH﴿, the European Pharmacopoeia (Pharmacopoeia Europaea -Ph. Eur.﴿, the United States Pharmacopeia (USP﴿ and other applicable guidelines. Additionally, it possesses the technical facilities to store and test samples undergoing stability testing, to test raw materials used in production processes, and to apply a range of validated biological and physicochemical methods used for product control. Thanks to its experience and expertise in working within the highest cleanliness classes, it supports sterile product filling processes and the daily monitoring of environmental conditions. The Procurement and Logistics Department has the technical facilities to enable transport under controlled conditions and a team responsible for carrying out procurement processes. From an operational perspective, the dedicated Project Management Department oversees the proper execution of orders. It is responsible, among other things, for monitoring the progress of project work and mitigating risks, and in the case of projects carried out in partnership, it coordinates the work to ensure the integrity of the service provided.
ResourcesThe production facility in Konstantynów Łódzki, with an area of 6,331 m², together with a plot of land covering 1.9 hectares, operating within the Łódź Special Economic Zone, as well as leased laboratory and office premises in Łódź on Fabryczna Street, provide the infrastructure necessary for Biotech operations.
As at 31 December 2025, the Company employed 205 people under employment contracts. Mabion's current resources, developed through many years of research and development, include fully functional analytical laboratories, a manufacturing area, as well as technical know-how and expertise in quality systems required for production and analysis. Certifications and authorisations held include: GMP for manufacturing and analysis, and ISO (environmental protection, occupational health and safety﴿.
Mabion has undergone numerous audits and inspections, operating within quality systems for pharmaceutical production since 2011, which has led to the development of a mature quality system and makes the Company a reliable CDMO partner.
The technology for manufacturing therapeutic proteins is a rapidly developing area of medical biotechnology, being explored by the world's largest pharmaceutical companies. The Company is a pioneer in the field of modern biotechnology not only on a national scale, but also across Central and Eastern Europe. The global suppliers of biological medicines remain exclusively large international pharmaceutical corporations. Within a few years, Mabion S.A. has acquired the expertise to manufacture any biotechnological medicine, from the early development phase, through the selection of the technological pathway, to the production of the finished medicine.
The Company possesses expertise that is unique on the Polish market in the design, development and manufacture of highly specialised protein-based medicines. Since 2021, this has enabled the Company to diversify its operations by offering
services under the CDMO model. By leveraging its expertise, the Company is becoming a natural partner for other entities at all stages of the development and manufacture of biological medicines.
Information regarding the collective experience and expertise of key technical personnelMabion's organisational structure comprises the following departments and divisions: Research and Development, Manufacturing, Quality Control, Quality Assurance, Administration, Finance, Maintenance, Business Development, Project Management, Purchasing and Logistics, Marketing Office, and support units such as: Health and Safety, Data Protection Officer, Regulatory Affairs Officer, independent Qualified Persons and Pharmacovigilance - the Company's organisational chart is presented in section 1.3 of this Report. In 2025, the capabilities of the Business Development Department were expanded and developed to enable the dynamic acquisition of clients within the Biotech business and to build the recognition of the Mabion brand. Over the course of its existence, the Company has assembled a stable and experienced workforce, both in terms of technical expertise and operational capabilities. An integral part of the Company's development is its commitment to staff development; therefore, Mabion takes great care to ensure its staff have the opportunity for continuous improvement and the enhancement of their professional skills. The Company also cooperates with universities and public institutions on joint projects combining academic knowledge with business experience (see section 9.10.4.4 of the Non-Financial Statement for further details﴿.
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Assessment of the feasibility of investment plans
Taking into account the activities carried out during 2025 and up to the date of publication of this Report, the development prospects and external and internal factors relevant to the Company's future operations and development, as presented in sections 2.2-2.4 of this Report, the Management Board of Mabion S.A. assesses the Company's adopted investment plans as feasible, provided that additional financing is secured, as well as strategic partnerships are established and contracts are secured. Operating cash flows from contract execution, supplemented by external financing, will enable the implementation of strategic objectives for the Company's development and the achievement of its business goals.
In accordance with the assumptions of the 2025-2030 Strategy, the Company will make investments primarily in support of its ongoing innovative development especially in the form of the novel technology continuous manufacturing for biologics, taking into account the market needs to massively reduce the COGs and to extend the addressable market
The Company's financial liquidity, and thus its ability to implement its investment plans, may be adversely affected by:
the inability to secure further financing;
difficulties in acquiring customers and generating revenue from contract fulfilment;
a significant increase in energy costs and other fixed costs;
customer insolvency;
disruptions in the supply chains for production materials;
changes to work schedules;
inability to carry out contract manufacturing at the planned level;
restrictions on financing for supplies by partners commissioning production;
rising infrastructure investment costs and a lack of sufficient funding necessary to expand production capacity;
delays in the refund of value added tax (VAT﴿.
The feasibility of implementing the investment plans adopted under the 2025-2030 Strategy is also influenced by the risk factors and threats identified in section 6 of this Report.
- Key intangible assets
Mabion's key intangible assets include technological know-how, process expertise, experience in the development and manufacture of protein-based therapeutic products and ATMPs, including the development of protein production processes, analytical testing, technology transfer, validation, the scaling up of production processes, and the manufacture of active pharmaceutical ingredients and finished products in collaboration with strategic partners. Mabion has many years of experience in the development and manufacture of biological medicines using mammalian and insect cell cultures, as well as in the characterisation of recombinant protein-based biopharmaceuticals, including monoclonal antibodies (mAbs﴿ and vaccine antigens. This expertise is reflected in the quality of our processes, as evidenced by GMP and ISO certification, as well as a track record of successful regulatory inspections.
Mabion operates on the basis of the knowledge and experience of its highly qualified management and research staff. These are individuals with unique expertise in the development of biosimilars, biotechnology process engineering, comparative analytics and EMA/FDA regulations. The company also holds one patent, No. PAT.233560, entitled 'Method for obtaining a recombinant protein from a precursor', as well as bespoke IT solutions (LIMS﴿.
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Company's business model
COMPANY'S ENVIRONMENT
General characteristics and strategic importance of regulatory compliance-
Market environment
The CDMO market is characterised by enormous growth potential, driven by a steady increase in research and development expenditure in the pharmaceutical industry, a growing number of molecules in the development phase, and a rising tendency among pharmaceutical and biotechnology companies to use outsourcing2.
Forecasts indicate that the global Biotech market will grow from USD 184.9 billion in 2024 to approximately USD 368.7 billion by 2034, corresponding to a compound annual growth rate (CAGR﴿ of 7.2%3. This dynamic growth is driven, among other factors, by the rising demand for biologics resulting from an ageing population, which in turn leads to intensified work on new products and technologies4. In addition, favourable regulations, including those concerning biosimilars, increase their availability to patients compared to more expensive originator medicines5.
There is also an upward trend in the outsourcing of many functions, including manufacturing, due to the high specialisation and complexity of biological drug manufacturing processes6.
Outsourcing to specialised and agile partners allows companies to achieve cost benefits and shorten time-to-market7. The growth in the number of CDMO/CRDMO clients is also a result of the emergence of numerous start-ups and small and medium-sized enterprises, which are responding to the long-term and stable demand for biologics8. New projects require a flexible and tailored approach, and the constant need to increase efficiency and productivity is leading to a growing demand for contract manufacturing and support services. Due to financial challenges small and midsize pharmaceutical companies are searching for collaboration with partners like Mabion to optimise their financial exposure, research and development processes, as well as subsequent scaling and production.
Production sites in markets with high regulatory standards are preferred, which puts Mabion, located in the European Union and subject to the regulations of the European Medicines Agency (EMA﴿. Mabion offers a wide range of services enabling project development from the gene construct stage to a commercial product manufactured in accordance with GMP standards, with full analytical and regulatory support. The wide range of services enhances the competitiveness of the company's offering, and over 18 years' experience in product development, confirmed by its collaboration with Novavax, makes Mabion an attractive Biotech partner for small, medium and large enterprises alike.
The market for biological CDMO services remains structurally growing, but at the same time is becoming more demanding in terms of costs structure, enhanced service offering, competition and customer expectations. On the one hand, it is driven by the growing importance of biological medicines and advanced therapies, as well as outsourcing as a lasting trend in the biopharmaceutical value chain. On the other hand, the market is experiencing periods of volatility (post-COVID-19 demand adjustments, venture capital funding constraints, 'patent cliffs' and rising cost pressures﴿, which intensifies price competition and forces greater flexibility, speed of delivery and quality resilience from CDMOs9. With the novel business model Mabion is offering the bridge form finance and speed perspective to co-ownership of products to be launched on the market.
Mabion can meet the growing demand for the production of therapeutic proteins across various categories of biologics produced in mammalian cells. This trend stems both from the growing role of biological products globally and from the fact that, for many therapeutic proteins, mammalian systems are the industry standard due to the required post-translational modifications and the expected quality profile10.
Furthermore, Mabion, being aware of the increasing competition in the CDMO market, recognises significant growth potential in the medium and long term in collaboration models that go beyond the traditional "client-CDMO" relationship, in response to changing market conditions and the evolving nature of cooperation with clients and business partners. In particular, Mabion identifies opportunities in projects carried out under a Co-Cevelopment model, which involves the active engagement of both parties, the sharing of costs and project risks, as well as participation in the future economic benefits arising from the commercialisation of the solutions being developed. In line with this approach, Mabion is in advanced discussions with business partners with whom cooperation would be strategic and longterm, based on joint development and value creation. However, the CDMO market environment is becoming increasingly demanding: the market is fragmented and undergoing consolidation, whilst cost pressures and the pace of technological change are rising. As a result, sponsors increasingly prefer to work with a limited number of trusted business partners, expecting CDMOs not only to carry out manufacturing but also to co-manage risk, ensure supply chain predictability and demonstrate flexibility throughout the project. In addition, the profile of requests for proposals is changing: the proportion of projects related to new products and modalities (e.g. bispecific antibodies, ADCs, mRNA or cell therapies﴿ is growing, requiring more advanced analytics and tailored CMC solutions.
2 Precedence Research. Pharmaceutical CDMO Market Size and Growth Analysis (2024-2034﴿. https://www.precedenceresearch.com/pharmaceutical-cdmo-market
3 Grand View Research. Biologics Market Size, Share & Trends Analysis Report (2024-2030﴿. https://www.www.grandviewresearch.com/industry-analysis/biologics-market
4 IQVIA Institute. Global Trends in R&D: Overview Through 2024. https://www.iqvia.com/insights/the-iqvia-institute
5 Evaluate Pharma. World Preview 2023, Outlook to 2028 - The Future of the Pharmaceutical Market. https://www.www.evaluate.com/thought-leadership
6 EMA (European Medicines Agency﴿. Biosimilars in the EU: Information Guide for Healthcare Professionals. https://www.ema.europa.eu/en/documents
7 Nature Reviews Drug Discovery. The Growing Role of CDMOs in Drug Development. Nature, 2023. https://www.nature.com/articles
8 Biopharma Dive. The Rise of Single-Use Bioprocessing: Trends and Challenges. https://www.biopharmadive.com
9 https://alirahealth.com/wp-content/uploads/The-2024-Biologics-and-Advanced-Therapies-Contract-Manufacturing-Report.pdf
10 https://www.cphi.com/content/dam/esa/hn/cphi/en/brochures/CPHI-trend-report-outsourcing-trends-and-strategies.pdf
Thanks to the expertise it has developed, Mabion is able not only to support the early stages of drug development, but also to offer advanced characterisation of active substances and medicinal products, which is crucial for regulatory processes. This combination of experience, technology and flexibility sets Mabion apart from its competitors as a CDMO with global potential. The importance of advanced analytics is further increasing in the context of the evolving development pathways for biosimilars: regulators (e.g. the EMA﴿ indicate that, in selected cases, the scope of clinical data may be reduced if high structuraland comparable pharmacokinetics, which may reduce the need for a classic, extensive efficacy confirmation study (often equated with Phase III﴿. At the same time, the FDA is publishing guidelines on assessing the need for Comparative Efficacy Studies, which reinforces the role of quality in biosimilar product programmes. In response to an increasingly competitive and 'modality-driven' market environment, Mabion is adapting its development strategy (including a focus on Drug Substance and the development of partnership models, such as Co-development and areas aligned with global trends﴿ to increase value for customers and build long-term relationships in the face of fluctuating demand and competitive pressure11.
- Regulatory environment
The regulatory environment for biopharmaceutical service companies (CDMOs﴿ reflects the high standards and strict quality requirements applicable to the entire biopharmaceutical sector. These requirements are defined by regulatory agencies such as the FDA (Food and Drug Administration﴿, the EMA (European Medicines Agency﴿ and national authorities (e.g. the Polish Central Pharmaceutical Inspectorate, GIF﴿. Manufacturing and analytical operations for products intended for clinical trials or commercial use are subject to Good Manufacturing Practice (GMP﴿ principles, which ensure the appropriate quality, safety and efficacy of biopharmaceuticals. The regulations cover, amongst other things, the manufacturing facility, equipment, personnel, processes and quality control. Mabion has a long history, by national standards, of GMP certification for the sterile manufacture of biotechnological medicines.
The complexity of the manufacturing processes inherent to biological products, including monoclonal antibodies, recombinant proteins and protein-based vaccines, requires the Biotechs not only to strictly adhere to GMP principles, but also to adapt dynamically to evolving guidelines regarding quality, safety and efficacy. In 2025, this environment underwent a significant transformation, driven by regulators' efforts to shorten the time to market for innovations whilst increasing the resilience of supply chains.
Key regulatory changes in 2025New guidelines/recommendations or updates to previous guidelines concerning the regulation of biological medicines,
which may be relevant to the Company's operations and further development, are set out below.
"Reflection paper on a tailored clinical approach in biosimilar development" (EMA/CHMP/424987/2023﴿ published by the EMA in April 2025.
This document represents one of the most significant turning points in the European regulatory strategy for biosimilars. It shifts the burden of proof for biosimilarity from clinical trials to advanced analytics, which is the core domain of CDMO activity. A key aspect of the new regulations is the option to waive comparative Phase III clinical trials (efficacy﴿, provided that analytical and pharmacokinetic data of sufficient quality are submitted. For a biological CDMO, this represents a transformation from the role of a 'manufacturing contractor' to that of an 'analytical and strategic partner', where the quality of laboratory data directly determines the client's success in obtaining marketing authorisation.
The elimination of lengthy and costly Phase III trials opens up a range of market opportunities for the Company - as reducing the time and costs of biosimilar drug development (time-to-market﴿ encourages smaller biotech players to outsource production, which directly increases the pool of available projects in the early development phase. Once the new guidelines are fully implemented, a wave of new biosimilar development projects can be expected to emerge, projects which were previously put on hold due to clinical risks and costs.
Similar positions to that of the EMA have also been presented by other regulatory agencies, including the FDA, TGA and Health Canada.
New regulations concerning variations (changes to marketing authorisations﴿, based on Commission Delegated Regulation (EU﴿ 2024/1701.
These regulations came into force on 1 January 2025. The most significant changes included a complete transition to digital documentation (electronic application forms (eAF﴿, integration of documentation with PLM (Product Lifecycle Management﴿ systems﴿, the introduction of mandatory annual notifications for minor variations (Type IA﴿, the introduction of new rules for grouping changes, and the simplification of procedures for COVID-19 and influenza vaccines. The new regulations may help biopharmaceutical companies streamline the implementation of changes to manufacturing methods or raw material suppliers.
Act of 12 September 2025 amending the Pharmaceutical Law Act (Journal of Laws 2025, item 1416﴿:
An update to the Pharmaceutical Law, tightening the qualifications for Qualified Persons, with a closed list of degree programmes. This affects the biopharmaceutical sector in Poland through the potential need to adapt staffing.
udraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 4 (Documentation﴿, EMA, July 2025.
11 https://www.ema.europa.eu/en/news/streamlining-development-assessment-biosimilar-medicines
An update to Chapter 4 on documentation in GMP, highlighting the importance of compliance, support for new technologies, hybrid solutions and risk management principles in data management systems. It impacts the biopharmaceutical market by strengthening data integrity in paper, digital and hybrid formats.
EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Annex 11 (Computerised systems﴿, EMA, July 2025:
An update to Annex 11 concerning the lifecycle management of computerised systems, with an emphasis on QRM, supplier oversight, data integrity, audits and security. It impacts the CDMO sector through the need to strengthen digital controls in manufacturing.
ICH Q3E Guideline for Extractables and Leachables (Draft﴿, ICH, August 2025:
New guideline on extractables and leachables (E&L﴿, covering risk management principles, chemical testing, analytical thresholds and safety assessment throughout the product lifecycle.
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry (Final﴿, FDA, September 2025:
The final version of the FDA guidance on comparative analytical testing for therapeutic protein biosimilars, with an emphasis on a risk-based approach. It impacts the biopharmaceutical market by enabling more efficient development of biosimilars. The use of clear process engineering pathways by CDMOs can shorten project lead times and reduce costs.
As in previous years, Mabion verifies the compliance of new provisions with its internal quality system and makes the necessary modifications where required. Importantly, none of the changes described have a negative impact on the Company's current potential or its further expansion in the CDMO market. On the contrary, the simplification of the clinical development pathway for biosimilars by the EMA and other regulatory agencies is likely to have a positive impact on demand for CDMO services for biologics. This applies in particular to companies such as Mabion, which have many years of experience in the development and manufacture of this class of medicines.
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Market environment
MAJOR EVENTS
AND ACTIVITIES OF THE COMPANY
Conclusion of annexes to the agreement for the manufacture and supply of a line for leak testing and optical inspection of primary packaging-
Products and services provided by the Company
Mabion is an integrated biopharmaceutical company and a service provider. Mabion possesses expertise in the development and manufacture of protein-based therapeutic products, including the development of protein production processes, analytical testing, technology transfer, validation, scale-up of production processes, and the manufacture of active pharmaceutical ingredients and finished products in collaboration with strategic partners. Mabion has many years of experience in the development and manufacture of biological medicines using mammalian and insect cell cultures, and in the characterisation of recombinant protein-based biopharmaceuticals, including monoclonal antibodies (mAbs﴿ and vaccine antigens.
During the reporting period, i.e. in 2025, the Company focused its activities on the following key areas:
executing commercial contracts for partners in the field of contract manufacturing, analytics and development;
implementation and verification of platform solutions for recombinant protein production processes, aimed at expanding capabilities and increasing competitiveness in the provision of contract manufacturing and development services;
tendering and business negotiations as part of building the Company's CDMO order portfolio.
The Company's sales revenue in 2025 was generated primarily from services provided to Novavax, Inc.
Cooperation with Novavax, Inc.In 2025, the Company continued its activities under the CDMO service project for Novavax, Inc., based in the USA (hereinafter: Novavax﴿. The cooperation with Novavax is based on a Manufacturing Agreement concluded in 2021 for the contract manufacturing of an active substance, i.e. the COVID-19 vaccine antigen known as Nuvaxovid® (the product﴿, as well as additional orders. The Manufacturing Agreement with Novavax remains in force until the end of 2026.
In September 2024, Novavax expanded the scope of analytical work carried out by Mabion, as a result of which the Company carried out the transfer/validation/verification of selected analytical methods using current variants of the SARS-CoV-2 rS protein in the fourth quarter of 2024, and in the third quarter of 2025, it carried out work related to routine analysis of DS and DP samples of the Novavax product in accordance with GMP standards, stability testing samples, as well as the transfer and validation of analytical methods for methods selected by Novavax. In addition, in the second half of 2025, as part of additional contracts, the Company carried out work related to the qualification of critical reagents, positive control and reference standard qualifications, and analysed process samples and CIC product samples supplied by Novavax. Work related to routine analysis is ongoing and was carried out in 2025. It will also be carried out throughout 2026, depending on the number of samples supplied for analysis by Novavax.
In 2025, the Company provided analytical services to Novavax in accordance with the signed Statements of Work (SOWs﴿, as set out in the table below.
Table 3. Additional orders carried out in 2025 under the current Manufacturing Agreement between Mabion and Novavax
Lp. Order name Order date ScopeAdditional analytical services for Novavax in the field of analytical work related to the development,
SOW#1
SOW#9
7 October 2021
(Annex 1
of 22 September
2022, Annex 2 of 4 April 2023﴿
23 November 2022
(Annex No. 1 of 14 April 2023﴿
transfer and validation/verification of analytical methods for the active substance (DS﴿ and finished product (DP﴿ of rS SARS-CoV-2 protein samples of Novavax product variants,
and the testing of DS and DP samples of Novavax products as part of contract analytical testing of samples in the area of quality control (QC﴿.
Order in progress. The task is ongoing, depending on the analytical work orders signed.
Development of a method and performance of peptide mapping analysis for the active substance (DS﴿ and the finished product (DP﴿ of rS SARS-CoV-2 protein samples from Novavax products.
Assignment in progress. The task is ongoing, depending on the samples supplied for analysis.
SOW#11 26 June 2024
Feasibility assessment and validation of a new analytical method (based on peptide mapping technology﴿ and regular testing of a new product being developed by Novavax - a combined influenza and COVID-19 vaccine (COVID-influenza combination, CIC﴿.
Assignment in progress. The task is ongoing, depending on the samples supplied for analysis
Cooperation with the Instituto de Biologia Molecular do Paraná - IBMPOn 13 April 2025, the Company entered into a framework agreement with Instituto De Biologia Molecular Do Paraná, based in Brazil (hereinafter: IBMP﴿, for the provision of services relating to process development and the production of material for clinical trials, and received the first order (Statement of Work, 'SOW#1'﴿. The subject of SOW#1 is the provision of services in the following areas: cell line development, process development, manufacture of products for pre-clinical and clinical trials, development and validation of analytical methods, and preparation of the necessary documentation. Selected services are provided by the Company in cooperation with subcontractors. In 2025, the Company carried out the project in accordance with the schedule agreed with the client. An analysis of the product's critical quality attributes was performed and an analytical strategy for the project was developed; seven analytical methods were developed, and further methods necessary for product evaluation are under development. The reference drug, constituting the starting material necessary for the development of analytical methods, was obtained. In parallel, activities relating to logistics services, documentation work and the development of the purification process are being carried out on an ongoing basis. Gene synthesis, cloning and transfection were carried out as part of the work on cell line development conducted in collaboration with Sartorius Stedim Cellca, as well as the production of material on a 50L scale, which enabled the Company to commence work on the development of the product purification process. Following a decision by the client, it is necessary to optimise the cell culture process, which entails expanding the scope of work. After the balance sheet date, the parties, under the signed change order, expanded the scope of work to include additional process optimisation together with a DoE analysis. The expansion of the scope necessitated an update to the project schedule, which was accepted by the client without comment.
On 18 August 2025, the Company entered into a further order with the Client under the Framework Agreement (Statement of Work, 'SOW#2'﴿. The subject matter of SOW#2 is the transfer of technology for the manufacture of the active pharmaceutical ingredient to a manufacturing site designated by the Client, including the transfer of the necessary documentation, the manufacturing process and the analytical methods necessary for in-process control and product batch release.
The completion date, final scope and duration of the contract will be agreed at a later date and are dependent on the progress of work carried out under SOW#1.
Work for Novalgen LtdIn 2025, the Company continued to carry out work for Novalgen Ltd - a UK-based pharmaceutical company developing immunotherapeutic products. The work was carried out on the basis of orders received in August 2024 and covered stability testing of the active substance (AS﴿ and the finished product (FP﴿. In 2024, the transfer of documentation and data provided by the client was completed, and the first pilot batch was produced. In the first half of 2025, work on the transfer of analytical methods was completed, the production of an engineering batch was carried out, a full range of analytical tests on the engineering batch was performed for both the active substance and the finished product, GMP-compliant batch production was carried out, analytical testing of the manufactured GMP batch was performed for both the DS and the DP, and the product was released for the client's use. Both processes - the production of the engineering batch and the GMP batch - were carried out according to plan, whilst maintaining all necessary quality standards and compliance with the client's requirements. Immediately following the completion of the engineering and GMP batches, stability studies were initiated; due to their nature, these are long-term studies. Stability studies for the active substance (AS﴿ will continue until the second quarter of 2026, whilst those for the finished product (FP﴿ will
conclude in the third quarter of 2027. In addition, work related to the further optimisation of the ELISA Potency method was carried out in the last quarter of 2025 as part of an additional contract.
Performance of the contract with WPD Pharmaceuticals Sp. z o.o.On 17 April 2025, the Company entered into an agreement with WPD Pharmaceuticals Sp. z o.o. for the provision of services involving the development of analytical methods for a drug candidate in the form of a recombinant protein conjugated with a cytotoxic substance and a protein intermediate for the purposes of production process control, characterisation of the protein intermediate and the conjugate, and release testing. From the date the agreement came into force, i.e. 19 May 2025, the Company carried out the project in accordance with orders placed by the client and based on the approved work schedule. A study plan was issued, test materials were delivered to Mabion (both the
drug candidate in the form of a recombinant protein conjugated with a cytotoxic substance and the protein intermediate﴿, and laboratory work commenced on the development of analytical methods to assess the structure and physicochemical parameters of the protein intermediate. In 2025, 2 out of 6 ordered packages were completed. After the balance sheet date, the remaining commissioned work packages were completed and the project was settled in accordance with the substantive requirements specified in the orders, the scopes applicable to the ordered packages, and the completion deadline, in the first quarter of 2026.
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Sales markets
In 2025, nearly 95% of the Company's sales revenue consisted of export revenue, which was due to the fact that the main recipients of the Company's services are Novavax, Inc., based in the USA, Novalgen Ltd, based in the UK, and Instituto De Biologia Molecular Do Paraná - IBMP, based in Brazil. The main customers are in no way affiliated with the Company.
Table 4. Mabion S.A.'s sales revenue broken down by domestic and foreign markets
Sales destination PLN thousand 2025 % PLN thousand 2024 %Domestic
800
5.07%
245
0.36%
Exports
14,957
94.93%
68,774
99.64%
Source: Company's own analysis
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Supply sources
In 2025, the Company was engaged in work across a wide range of areas (including both in-house projects designed to enhance the Company's appeal in the CDMO market and contract work﴿ -small-scale process work, process work related to scaling up, analytical research and development work, and analytical work in quality control. The high level of technology developed at Mabion, as well as the diverse range of project topics, means that the Company utilises a wide array of products and services available on the market. This is reflected in the number of supply sources it uses. The Company collaborates with suppliers regarding the supply of process equipment, consumables, substances, and services related to the projects it undertakes.
The manufacture of an advanced biotechnology product, such as a monoclonal antibody or a protein antigen for a vaccine, requires the maintenance of appropriate sterility and cleanroom conditions, as well as certified starting materials, including single-use materials. The final product is subject to release procedures by the Quality Control Department, which necessitates the use of appropriately characterised reagents or the commissioning of external analyses by relevant certified bodies.
During the period covered by this Report, the Company did not engage in the production of its own finished goods (other than in connection with the performance of the CDMO contract﴿; therefore, purchases and inventories consist mainly of materials used for research and development purposes. Raw materials
purchased by the Company and used to fulfil a CDMO contract are recognised in the profit and loss account at the time of purchase, rather than at the time of actual use in production, where such raw materials have no alternative use. Raw materials supplied and subsequently used in the contract manufacturing process are specifically identifiable. The Company has no right to use these raw materials for purposes other than contract manufacturing, and other conditions indicate that control over the raw materials is transferred to the client by the Company at the time of acquisition of the raw materials. Consequently, the Company does not recognise purchases of raw materials acquired for the purpose of fulfilling a contract manufacturing agreement in the balance sheet under the heading 'inventories'. Nevertheless, it should be noted that the process of delivering raw materials and ensuring their adequate levels in accordance with the applicable agreement remains the responsibility of the Company.
In 2025, the Company identified three suppliers of materials or services (including suppliers providing supplies for the performance of the CDMO contract﴿ with whom the value of turnover exceeded 10% of the Company's total sales revenue. This group includes PGE Obrót S.A., LabVantage Solutions Limited and Collaborate Global Ltd. The Company does not identify any dependence on any of its suppliers. In order to prevent potential risks relating to dependence on suppliers, the Company always considers alternative solutions and monitors the market for manufacturers and suppliers. These measures allow for a degree of supplier diversification. The Company exercises due diligence
to ensure that all orders are prepared well in advance, so as to prevent any potential delays in the supply chain.
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Agreements entered into or terminated in the financial year of 2024 and after the balance-sheet date
- Material agreements in the area of operations
On 9 January 2025, Mabion entered into an amendment with Bonfiglioli Engineering srl (the Supplier﴿ to the agreement of September 2023 for the manufacture and supply of a line for leak testing and optical inspection of primary packaging. Under the amendment, the parties modified the parameters of the ordered equipment to increase its capacity to analyse an additional 2R vial format; this was the Company's response to enquiries from potential customers and was intended to enable the Company to best align its resources with their requirements. In connection with the changes made, the parties agreed on a delivery date for the equipment with the new parameters in the second quarter of 2025 and a net remuneration for the Supplier of EUR 0.87 million (previously: EUR 0.83 million﴿. Subsequently, on 25 June 2025, Mabion entered into an amendment to the contract with the Supplier, under which the parties agreed on a new delivery date for the equipment in the fourth quarter of 2025; however, due to a change in the Company's Strategy adopted on 14 November 2025, the Company postponed acceptance of the equipment and suspended it pending further decisions by the Management Board in this regard. Under the agreement, the Supplier was obliged to manufacture, deliver and install at the Company's premises a device for the automatic inspection of products in glass vials, comprising optical assessment of the product and testing of packaging leak-tightness, in accordance with the specifications set out in the agreement. The equipment features a state-of-the-art measurement and control system, and its design complies with GMP requirements as well as national and international standards. The purchase of the product inspection line was part of the implementation of the Company's Development Strategy for 2023-2027, enabling the acceleration of quality control processes for finished products and the provision of quality control services for finished products on a significantly larger scale.
The Company announced the conclusion of the agreement in Current Report No. 22/2023 dated 6 September 2023, and the conclusion of annexes to the agreement in Current Reports No. 1/2025 dated 9 January 2025 and No. 16/2025 dated 25 June 2025.
Signing of a framework agreement and order with Instituto De Biologia Molecular Do Paraná - IBMP and extension of cooperation through the conclusion of a new orderOn 13 April 2025, the Company entered into a framework agreement with Instituto De Biologia Molecular Do Paraná -IBMP, based in Brazil (the Client﴿, for the provision of services
relating to process development and the production of clinical trial material (the Master Development and Clinical Supply Services Agreement, the Framework Agreement﴿. IBMP is a Science and Technology Institute that supports the development of science and technology in Brazil and supplies safe, high-quality healthcare products to the public healthcare network. The Institute engages in joint research and innovation projects with national and international partners, supporting scientific and technological progress worldwide.
The Framework Agreement with IBMP is unconditional. Its purpose is to define the general terms of cooperation between the parties and the rules governing the provision by the Company to the Client of services relating to process development and scaling, including the manufacture of a preclinical trial batch in accordance with GMP standards, the development and validation of analytical methods for process and product control, and the transfer of process technology to the Client. Individual services are provided by the Company on the basis of Statements of Work (SOW﴿ submitted by the Client on a case-by-case basis, in accordance with the scope of work and cost estimate set out therein. The framework agreement has been concluded for a period of 5 years and does not impose a minimum value on the orders that the Client is obliged to place. At the same time, the Framework Agreement includes standard clauses regarding the possibility of its termination. The Company's total liability shall not exceed the total fees paid by the Client.
Upon the conclusion of the Framework Agreement, the Client placed its first order (Statement of Work, SOW#1﴿. The subject of SOW#1 is the provision of services in the following areas: cell line development, process development, production of a product for pre-clinical and clinical trials, development and validation of analytical methods, and preparation of the necessary documentation. Selected services are provided by the Company in cooperation with subcontractors. The total net value of the contract is approximately PLN 19,0 million (converted at the USD exchange rate of 11 April 2025﴿, of which approximately 20-25% will constitute remuneration for subcontractors. Payments, denominated in USD, for the performance of the work are linked to the work schedule and are therefore made as the work progresses.
Upon signing the Framework Agreement, the Company and the Client commenced preparatory work. The commencement of services under the contract was conditional upon the Client entering into an agreement with a third party regarding project financing and the subcontractor's formal acceptance of the Company's tender for the performance of part of the work under the contract. The Company expected these conditions to be met by the end of the second quarter of 2025. On 30 June 2025, the Company became aware that the above conditions had been met and consequently commenced the performance of the contract for the Client.
The project is being carried out in accordance with the plan and in close cooperation with the client; further details on the status of the work are provided in section 4.1 of this Report.
On 18 August 2025, the Company entered into a further contract with the Client under the Framework Agreement (Statement of Work, SOW#2﴿. The subject of the SOW#2 contract is the transfer of technology for the manufacture of a medicinal substance to the manufacturing site designated by the Client, including the transfer of the necessary documentation, the production process and the analytical methods required for in-process control and product batch release. The Company's net remuneration for project management and administration, as well as the technology transfer to the Client, will amount to the equivalent of approximately PLN 1.6 million (converted at the USD exchange rate as at 18 August 2025﴿. The above remuneration does not include the costs of materials, logistics services and other external costs specified in SOW#2. Payments will be contingent upon agreed schedules and progress of work. The order completion date, its final scope and duration will be agreed at a later date and are dependent on the progress of work carried out under SOW#1.
Securing orders from the Client constituted a significant event, confirming the effectiveness of the Company's tendering activities and its potential for further development in the CDMO sector. The conclusion of SOW#2 was additionally significant from the perspective of expanding cooperation with the Client into a new area, following the positive progress of the work carried out to date under the first contract.
The Company reported on the conclusion of the Framework Agreement and the first order in Current Report No. 4/2025 dated 14 April 2025. The Company reported on the fulfilment of the conditions necessary to commence the execution of SOW#1 in Current Report No. 17/2025 dated 30 June 2025, and on the conclusion of SOW#2 in Current Report No. 25/2025 dated 18 August 2025.
Conclusion of a strategic cooperation agreement with Sartorius Stedim Cellca GmbH for the joint commercialisation of servicesOn 13 April 2025, Mabion entered into a strategic cooperation agreement with Sartorius Stedim Cellca GmbH, based in Germany (Sartorius﴿, aimed at the joint commercialisation of services and the implementation of joint projects for potential clients in the biopharmaceutical industry (Cooperation Agreement﴿. Sartorius is a leading German biotechnology company specialising in the development of cell lines and biopharmaceutical production technologies. It is part of the Sartorius AG group, a global leader in laboratory and biopharmaceutical solutions, listed on the Frankfurt Stock Exchange.
The primary aim of the collaboration with Sartorius is to integrate the service offerings of both entities, enabling potential clients to achieve greater synergy and benefit from a comprehensive solution combining Sartorius' services in the establishment of stable cell lines and cell culture process development on a laboratory scale with the Company's services in product purification process development, process and product analytics, and process and production scaling for clinical trials and commercial operations. In accordance with the Cooperation Agreement, the joint implementation of projects will be
beneficial primarily due to the complementary nature of the services offered by both entities, which will enable the delivery of high-quality biological products to clients in a shorter timeframe than under a traditional sequence of sequential processes.
The cooperation agreement has been concluded for an indefinite period, with the possibility of termination upon prior notice in accordance with the terms set out in the agreement. The agreement does not provide for exclusivity for either party. The financial terms for the provision of services by the parties will be agreed upon on a case-by-case basis prior to the execution of a given project for a client, depending on the scope and terms of the contracted services.
The first joint project under the established cooperation is the execution of an order (for the aforementioned﴿ Instituto De Biologia Molecular Do Paraná - IBMP, which required Sartorius to accept the order placed by the Company. Mabion expected this to take place by the end of the second quarter of 2025. On 30 June 2025, the Company became aware that Sartorius had accepted the Company's order to carry out part of the work under the contract, which constituted fulfilment of the above condition. Subsequently, the Company - in accordance with the schedule - proceeded, together with its partner, to implement the subsequent stages of the project.
The cooperation agreement with Sartorius provides the Company with the opportunity to jointly conduct tender processes in the future and thereby acquire new clients, as well as enabling the expansion of the CDMO service portfolio, thus aligning with the objectives of the Company's Strategy for 2025-2030.
The Company announced the conclusion of the Cooperation Agreement and the first joint project under the established cooperation in Current Report No. 5/2025 of 14 April 2025, and reported on the fulfilment of the project implementation condition in Current Report No. 17/2025 of 30 June 2025.
Conclusion of an agreement with WPD Pharmaceuticals Sp. z o.o. for the provision of analytical method development servicesOn 17 April 2025, Mabion entered into a contract with WPD Pharmaceuticals Sp. z o.o. (the Client﴿ for the provision of services consisting of the development of analytical methods for a drug candidate in the form of a recombinant protein conjugated with a cytotoxic substance and a protein intermediate for the purposes of production process control, characterisation of the protein intermediate and the conjugate, and release testing (the Agreement﴿.
The Agreement was concluded subject to the condition precedent that the Client would enter into a grant agreement necessary for the implementation of the project covered by the Agreement. On 19 May 2025, the Company received notification from the Client that the latter had concluded a grant agreement, thereby bringing the Agreement for the provision by the Company of analytical method development services to the Client into force.
Under the Agreement, the Company carried out a project aimed at developing an analytical panel necessary to characterise specific protein molecules and a recombinant protein-cytotoxic substance conjugate. The broad analytical panel defined in the Agreement included methods for assessing the structure, physicochemical parameters and biological activity of the molecules. The Agreement was implemented in stages, during which work was carried out on specific sets of methods.
The deadline for completion of the Agreement was set for the first quarter of 2026. The Company received orders for the execution of six work packages, two of which were completed in 2025. After the balance sheet date, the remaining commissioned work packages were completed and the project was settled in accordance with the substantive expectations defined for the commissioned packages, and within the scope and deadlines specified in the commissioned packages. The final remuneration for the Company for the contracted and completed work packages amounted to approximately PLN 1.3 million net (the originally estimated remuneration was approximately PLN 2.0 million net, and the reduction in remuneration is due to the Client's withdrawal from part of the originally planned work﴿. The Company reported on the conclusion of the Agreement and the fulfilment of the condition precedent in current reports No. 6/2025 of 17 April 2025 and No. 12/2025 of 19 May 2025.
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Material agreements financing the Company's business
In the financial year 2025 and up to the date of publication of this Report, the Company has not terminated any agreements relating to loans, borrowings or other forms of financing of the Company's operations.
In the financial year 2025 and up to the date of publication of this Report, the Company had not granted any loans.
In the 2025 financial year and up to the date of publication of this Report, the Company was granted the following loans:
Loan agreement with Twiti Investments Ltd.On 24 October 2025, the Company entered into a loan agreement with Twiti Investments Ltd. for an amount of up to PLN 18 million for a period of 2 years. Under the agreement, the loan is made available at the Company's request, in full or in tranches, and bears interest at a fixed annual rate of 9.53%. The loan is intended to improve the Company's financial liquidity and for corporate purposes.
The making of the loan available to the Company was made conditional upon the Company fulfilling formal conditions relating mainly to activities connected with the creation of security. The Company has fulfilled all conditions and taken all necessary steps to create the security required by the agreement. The loan is secured by a mortgage on the Company's real estate, a registered pledge on four items of movable property (bioreactors﴿ owned by the Company, an assignment of rights under movable property
insurance contracts, and a declaration by the Company of submission to enforcement proceedings in accordance with Article 777 of the Code of Civil Procedure.
The agreement contains standard provisions regarding the Company's obligations and the consequences of breaching them, such as an increase in the interest rate or the declaration of the entire or part of the drawn-down loan amount as immediately due and payable, in the event of, amongst other things, failure to repay the loan on time. The agreement provides for the possibility of converting all or part of the loan, together with interest, into shares in the Company at any time, at the request of Twiti Investments Ltd. The share price for the conversion will be equal to the market price of the shares, taking into account a 20% discount, or, in the event of a share issue by the Company, will be equal to the share price offered to other investors.
The loan granted constitutes the fulfilment of the declaration of support for the Company made by Twiti Investments Ltd. in a letter of support, as disclosed by the Company in its financial statements for 2024. The loan agreement was concluded on the terms agreed by the parties in the Term Sheet, which the Company received, signed by Twiti Investments Ltd, on 29 September 2025. Obtaining the loan has enabled the Company to carry out its current operational activities and to maintain its readiness and capacity to execute new contracts.
The Company announced the conclusion of the loan agreement in Current Report No. 32/2025 of 24 October 2025, and the receipt of the Term Sheet in Current Report No. 30/2025 of 29 September 2025.
Loan agreement with ACRX Investments LimitedOn 9 February 2026 (an event after the balance sheet date﴿, the Company entered into a loan agreement for up to PLN 6 million with an unrelated party, namely ACRX Investments Limited, with its registered office in Nicosia, Cyprus (the Lender﴿.
In accordance with the agreement, the loan was made available in full on 10 February 2026 at the Company's request. The loan bears interest at a fixed annual rate of 9.53% and will be used to improve the Company's financial liquidity and for corporate purposes. The loan was granted for a period of 6 months from the date of disbursement. The agreement provides for the possibility of converting all or part of the loan, together with interest, into shares in the Company at any time, at the Lender's request. The share price for the conversion will be equal to the market price of the Company's shares, taking into account a 20% discount, or, in the event of a share issue by the Company, will be equal to the share price offered to other investors.
In accordance with the original terms of the agreement, the loan was to be secured by: (i﴿ a mortgage on the Company's real estate, (ii﴿ a registered pledge on movable assets (selected bioreactors and a system intended for cell line development﴿ owned by the Company, and (iii﴿ a blank promissory note together with a promissory note declaration. By an annex dated 2 March 2026, the Parties modified the security in such a way that the blank
promissory note together with a promissory note declaration was replaced by a declaration of the Company's submission to enforcement in accordance with Article 777 of the Code of Civil Procedure.
The company has established a mortgage on its real estate and filed a declaration of submission to enforcement in accordance with Article 777 of the Code of Civil Procedure. With regard to registered pledges, the parties have agreed that the pledge agreement will be executed and the relevant applications filed with the registry court by May 31, 2026.
The agreement contains standard provisions regarding the Company's obligations and the consequences of breaching them, such as an increase in the interest rate or the declaration of the entire or part of the utilised loan amount as immediately due and payable, in the event of, inter alia, failure to repay the loan on time. The loan agreement was concluded under Polish law.
The Company announced the conclusion of the loan agreement in Current Report No. 2/2026 dated 9 February 2026.
Conclusion of a loan agreement with CBC Co., Ltd.On March 13, 2026 (an event after the balance sheet date﴿, the Company's Management Board entered into a loan agreement with an unrelated party, namely CBC Co., Ltd., based in Tokyo, Japan ("Lender"﴿, for an amount of up to EUR 3.1 million ("Agreement"﴿.
Pursuant to the Agreement, the loan will be made available at the Company's request in two equal tranches, with the first tranche disbursed on March 17, 2026, and the second tranche on April 22, 2026.
The loan will be used to improve the Company's financial liquidity and for corporate purposes.
The loan was granted for a term of 3 years from the date of disbursement. The Agreement provides for the possibility of converting all or part of the loan, together with interest, into shares of the Company at any time, at the Lender's request. The share price for the conversion will be equal to the market price of the Company's shares as of the date of signing the Agreement, taking into account a 20% discount, or, in the event of a share issuance by the Company, will be equal to the share price offered to other investors. The interest rate on the loan is 10.53% per annum until the Company's General Meeting adopts a resolution regarding an increase in the Company's share capital, enabling the conversion of the loan, and thereafter will be equal to the reference rate of the National Bank of Poland, plus a fixed margin of 2 percentage points.
The loan is secured by a mortgage on the Company's real estate, a registered pledge on movable property (selected bioreactors and production lines﴿ owned by the Company, and a declaration by the Company to submit to enforcement proceedings in accordance with Article 777 of the Code of Civil Procedure. The agreement contains standard provisions regarding the Company's
obligations and the consequences of breaching them, such as an increase in the interest rate or declaring all or part of the utilized loan amount immediately due and payable, in the event of, among other things, failure to repay the loan on time. The loan agreement was concluded under Polish law. CBC Co., Ltd. is a privately held company with a global reach, acting as an experienced operating entity and strategic investor. The entity specializes in the high-tech and life sciences sectors, focusing on long-term value creation through international development projects.
The Company announced the conclusion of the loan agreement in Current Report No. 5/2026 dated March 13, 2026.
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Sureties and guarantees
During the 2025 financial year, the Company neither granted nor received any sureties or guarantees.
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Transactions with related parties
The Company has disclosed transactions with related parties in Note 29 to the financial statements.
In the financial year 2025, the Company did not enter into any transactions with related parties on terms other than arm's length terms.
- Other major agreements
In 2025, the Company entered into agreements with 2bind, a company providing formulation development services (14 February 2025﴿, and ExcellGene, a supplier of cell lines (23 October 2025﴿. These agreements enable the Company to carry out development projects comprehensively, as well as to diversify its access to cell lines, thereby minimising technological and business risks. The agreements are framework agreements and the Company has the option to implement them when specific business needs arise on its part.
The value of the above agreements is not significant from a financial perspective, but is important in terms of building the Company's experience and gradually developing its client portfolio in the biotechnology market.
4.5. Significant factors and events affecting the Company's operations in the financial year 2025 and after the balance sheet date Fulfilment of the conditions of the licence to operate within the Łódź Special Economic ZoneOn 17 December 2025, the Company received a report on the inspection concerning the Company's fulfilment of the conditions of Permit No. 301 to operate within the Łódź Special Economic Zone (the Zone﴿ regarding the Company's incurrence of eligible investment expenditure within the Zone amounting to at least PLN 20 million by the end of 2024 and the completion of the investment by the end of 2024. On the basis of the audit activities
carried out, it was established that both of the aforementioned conditions of the permit had been fulfilled.
In the period from the date the permit was granted until 31 December 2024, eligible investment expenditure totalled over PLN 29.9 million. This expenditure related to increasing production capacity at the existing Mabion S.A. Medical Biotechnology Science and Industry Complex through the retrofitting of the production line and the purchase and installation of production equipment. The investment was completed on schedule, and the remaining conditions of Permit No. 301 were met by the Company in previous years, as reported by the Company in current reports No. 29/2017 dated 31 May 2017 and No. 26/2020 dated 23 June 2020.
Consequently, the Company has obtained the right to benefit, until the end of 2026, from a tax exemption of up to 45% of the maximum amount of eligible investment costs specified in the permit at PLN 26 million and the maximum amount of two-year eligible labour costs specified at PLN 0.65 million.
The Company reported on the above event in Current Report No. 34/2025 of 17 December 2025. The Company reported on the granting of Permit No. 301 in Current Report No. 2/2017 of 3 January 2017, and of changes to the aforementioned permit in current reports No. 9/2020 dated 7 February 2020 and No. 50/2021 dated 10 August 2021.
4.6 Main domestic and foreign investmentsIn 2025, the Company did not invest in securities and did not make any significant investments in financial instruments or significant investments in intangible assets, apart from expenditure related to the implementation of LIMS and QMS systems, which were mainly recognised in operating expenses.
During the period from 1 January 2025 to 31 December 2025, actual expenditure on fixed assets amounted to PLN 3,6 million, of which the most significant item, amounting to PLN 854,000, related to the purchase of a Cytiva Akta Pilot chromatograph, which was financed by a loan. The Company financed the remaining expenditure mainly from its own funds. Detailed information regarding liabilities in this respect as at the balance sheet date is presented in Note 14 to the Financial Statements.
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Products and services provided by the Company
COMPANY'S FINANCIAL AND ASSETS POSITION
by the laws of a non-member state (Journal of Laws of 2025,
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Accounting principles applied to the preparation of Financial Statements
The financial statements of Mabion S.A. have been prepared in accordance with International Financial Reporting Standards as adopted by the European Union ("IFRS"﴿ as at the reporting date.
The financial statements of Mabion S.A. for 2025 comprise:
a statement of financial position as at 31 December 2025; and, for the financial year from 1 January to 31 December 2025:
a statement of comprehensive income;
a statement of changes in equity;
a cash flow statement; as well as
notes to the financial statements containing a description of the accounting policies adopted and other explanatory information.
The financial statements cover the annual reporting period from 1 January to 31 December 2025 and the comparative period from 1 January to 31 December 2024.
The same accounting policies have been applied in the 2025 financial statements as in the 2024 financial statements. In 2025, there were no changes to the principles for determining the value of assets and liabilities or for measuring the financial result.
The financial statements for 2025 have been prepared in accordance with the going concern principle, which assumes that the Company will continue as a going concern for the foreseeable future, for a period of not less than 12 months from the balance sheet date (the assumptions underlying the application of this principle are set out in more detail in Note 3 to the financial statements﴿. Consequently, no adjustments have been made to the financial statements that might have been necessary had the going concern assumption not been valid.
The financial statements have been prepared on a historical cost basis, with the exception of certain assets and liabilities measured at fair value in accordance with IFRS. The financial statements, with the exception of the cash flow statement, have been prepared on an accrual basis.
The scope of the Company's annual report complies with the Regulation of the Minister of Finance of 6 June 2025 on current and periodic information provided by issuers of securities and the conditions for recognising as equivalent information required
item 755﴿.
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Discussion of the Company's financial results for 2025 and factors and unusual events having a material impact on the results achieved
In 2025, the Company conducted its operational activities consisting of:
a﴿ the performance of the Manufacturing Agreement signed with Novavax Inc. concerning the contract manufacturing of the active substance, i.e. the COVID-19 vaccine antigen known as Nuvaxovid®;
b﴿ the performance of an agreement signed with a UK-based immunotherapy company for the execution of three contracts covering process transfer, manufacturing and release of the product for clinical purposes, transfer, validation and development of analytical methods including stability testing, as well as the filling of the finished product, and its packaging, labelling and storage;
c﴿ intensifying sales activities aimed at securing new contracts and continuing to implement measures that position the Company as a fully integrated player in the CDMO market, by expanding the range of its expertise and services;
d﴿ developing the Company to enhance its competitiveness and attractiveness as a partner for the development and manufacture of biopharmaceutical products.
The expected expiry of the guaranteed active substance manufacturing contract at the end of May 2024 under the current contract with Novavax, and the potential to provide services at the manufacturing facility following the expiry of exclusivity, triggered the process of acquiring new clients.
Active tendering and sales activities resulted in the signing on 16 August 2024 of three contracts with a UK-based immunotherapy company for the performance of specific work on behalf of the client.The Company commenced work for the Client in September 2024, with completion scheduled for the second quarter of 2025. The value of the work commissioned under the current SOWs is approximately PLN 5.5 million (payments denominated in USD﴿. The measures taken and the need to maintain operational capacity to provide services, coupled with increased expenditure on sales and new customer acquisition and insufficient sales revenue, resulted in a net loss of PLN 62,614,000. Additional factors affecting the reported financial results included a write-down of property, plant, and equipment under construction (including the IMA packaging line and the Ebetech vial filling line﴿ in the amount of PLN 7,991,000. In 2025, the Company generated financial income of PLN 695,000, mainly from interest on deposits. During the reporting period under
review, the Company incurred a liability in the form of a loan from Twiti Investments Ltd. in the amount of PLN 18 million, of which PLN 10 million had been utilized as of the balance sheet date. These funds were transferred to the Company in two tranches-PLN 6 million in November and PLN 4 million in December 2025.
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Financial and non-financial performance indicators
In 2025, in accordance with the adopted accounting principles and policies, the Company recognised revenue from its core activities comprising the provision of CDMO production and sales services, production readiness services, and the provision of analytical and research services. The Company has presented the sources of the revenue generated in section 4.1 of this Report. In total, the Company's net sales revenue for 2025 amounted to PLN 15,757,000, whilst the gross loss on sales for 2025 amounted to PLN 17,415,000. The net loss for 2025 stood at PLN 54,655,000.
In connection with the net sales revenue achieved in 2025, the Company has set the following financial ratios for 2025:
EBITDA (i.e. operating profit adjusted for depreciation and amortisation﴿;
Return on assets (ROA, i.e. the ratio of net profit/loss to total assets at the end of the year﴿;
Return on equity (ROE, i.e. the ratio of net profit/loss to equity at the end of the year﴿;
eturn on revenue (ROR, i.e. the ratio of net profit/loss to total revenue﴿.
Revenue generated in 2025 resulted mainly from the performance of the contract, as well as additional orders for other entities under concluded agreements.
Table 5. Financial indicators
Financial indicators 2025 2024Income from sales PLN 15,757 thousand PLN 69,019 thousand
Gross profit on sales PLN (17,415﴿ thousand PLN 41,152 thousand
Net profit / (loss﴿ PLN (62,614﴿ thousand PLN (6,334﴿ thousand
EBITDA PLN (50,500﴿ thousand PLN 1,518 thousand
Total assets PLN 110,433 thousand PLN 159,472 thousand
Equity PLN 48,828 thousand PLN 111,442 thousand
Return on Assets (RoA﴿ (56.70﴿% (3.97﴿%
Return on Equity (ROE﴿ (128.23﴿% (5.68﴿%
Return on Revenues (ROR﴿ (397.37﴿% (9.18﴿%
The deterioration in financial ratios was caused by lower realised revenue from core operations following the completion in May 2024 of the guaranteed portion of the contract with Novavax, which had been carried out over previous years. The realised net loss had a direct impact on the negative ratios relating to return on assets, revenue and return on equity.
The Company's Management Board does not currently identify any non-financial performance indicators that are material to the assessment of the Issuer's development, results and financial position.
The financial ratios presented constitute Alternative Performance Measures (APMs﴿ within the meaning of the ESMA Guidelines on Alternative Performance Measures. Alternative Performance Measures are not financial performance measures in accordance with International Financial Reporting Standards and should not be treated as financial performance measures. These figures have not been audited by an independent auditor. Furthermore, the ratios are not uniformly defined and may not be comparable to ratios presented by other companies. APMs should be
analysed solely as supplementary financial information. The selected range of APMs presented was determined based on the Company's Management Board's assessment of individual indicators commonly used in financial analysis regarding their usefulness and reliability in the context of the current stage of the Company's business development. In the opinion of the Company's Management Board, the APM ratios presented may serve as a source of additional information on the Company's financial and operational position, as well as facilitate the analysis and assessment of the financial results achieved. There have been no changes in the method of calculating the individual APM ratios compared to 2024.
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Current and projected financial situation of the Company
The Company achieved financial results commensurate with the scope of services provided, in line with its business strategy.
During the current reporting period, the Company focused on the implementation of the agreement signed with Novavax Inc. and the execution of orders for analytical and stability testing of
the Client's samples, whilst simultaneously fulfilling the agreement signed with Novalgen Ltd. for orders covering process transfer, manufacturing and release of the product for clinical purposes; development and transfer, as well as the validation of analytical methods, together with stability testing of the active substance and the finished product. In addition, the Company carried out activities under the framework agreement signed with Instituto De Biologia Molecular Do Paraná, based in Brazil, for the provision of services relating to the development of the process and production of material for clinical trials of , and under the agreement signed with WPD Pharmaceuticals Sp. z o.o. for the provision of services involving the development of analytical methods for a drug candidate in the form of a recombinant protein conjugated with a cytotoxic substance and a protein intermediate for the purposes of production process control, characterisation of the protein intermediate and the conjugate, and release testing.
The completion of the Manufacturing Agreement and individual SOWs with Novavax-which in previous years had generated positive cash flows through the second quarter of 2024 and served as the primary source of funding for ongoing operations-made it necessary to meet the funding gap through new contracts or external financing.
A key factor in generating financial results and maintaining liquidity, including further increasing production capacity and the potential construction of a new plant, is securing new contracts in the CDMO sector (further information on the Company's financial liquidity is provided in Note 28.4 of the Financial Statements﴿. This affects both the raising of funds for day-to-day operations and the further financing of significant expenditure on the construction and equipping of the new plant.
Significant organisational changes, with particular emphasis on changes to the Management Board taking place at the turn of the third and fourth quarters of 2025, are expected to influence the pace of securing new contracts. In parallel, following an analysis of financing options (debt, equity or mezzanine financing from local or international investors or financial institutions﴿, the Company has taken steps to develop an optimal financing structure, which would be sourced from the following channels (either alternatively or through a combination﴿:
raising debt financing;
raising finance through a share issue;
securing an industry or financial investor to provide additional funding to the Company.
The scenario currently being pursued is to secure bridge financing from existing investors or other interested financing entities, which, in the Management Board's view, is the optimal source of short-term financing until the appropriate level of financing required in the medium term is secured. The current progress of the financing process is described below.
The Company's Management Board also continues to actively pursue activities aimed at securing debt financing and is taking
steps to increase capital through a share issue. In the Management Board's view, these activities constitute one of the key elements in meeting the estimated capital requirements. Securing an industry or financial investor who could significantly recapitalise the Company is one of three scenarios which the Company began to implement in April 2025 with the announcement of the update to the Strategy for 2025-2030.
Work is currently underway to increase the Company's capital in 2026 through a share issue, which will provide the Company with the funds needed to manage its liquidity over the coming months. This process has been initiated and is currently being implemented. It is estimated that, as a result of the planned issue, the Company will be able to raise additional funds up to the amount of the authorised capital of 8,081,163 shares, which, in the Management Board's opinion, will secure the Company's liquidity for the coming months. The planned issue will be a private placement and will not be conducted as a public offering. The Management Board considers that the risk of the capital increase through the issue of shares not being realised is negligible, but there is no certainty that such an issue will take place.
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Issues of securities
In 2025, the Company did not issue any securities.
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Financial instruments
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Financial instruments used
In accordance with the classification under IFRS 9, the Company holds the following financial instruments: long-term receivables, trade receivables, cash, repayable advances against distribution rights, trade payables, and loans and borrowings. A description of the above instruments, together with the methods of financial risk management and the exposure of individual instruments to currency risk, interest rate risk, credit risk and liquidity risk, is provided in Note 28 to the Financial Statements.
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Financial risk management objectives and methods
The Company's Management Board continuously manages risk across all significant areas of the Company's operations. Taking into account the transformation resulting from the Company's strategy, the situation in the pharmaceutical market and the CDMO sector, potential risks are monitored, reviewed and updated on an ongoing basis through:
anticipating and identifying potential risk areas;
in-depth risk analysis to actively prevent risks from materialising;
continuous monitoring and control of existing risks;
risk avoidance - refraining from certain high-risk activities;
taking preventive measures - developing an action plan and appropriate procedures for immediate implementation should the risk materialise;
maintaining risk at a pre-determined level or implementing risk mitigation plans;
reporting on identified risks and their nature;
compliance with the "Good Practices for Companies Listed on the Warsaw Stock Exchange".
Information on financial risk management is set out in Note 28 to the Financial Statements.
The Company's primary objective is to maintain its current and long-term liquidity using all instruments available on the market, in particular the fulfilment of current and future contracts with partners for contract manufacturing under the CDMO model or the provision of other services. The decision to expand production capacity by building a new plant has been put on hold until the current plant is operating at optimal capacity and revenue from contracts has been secured to enable the planned project to commence.
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Financial instruments used
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Dividend policy
The Company does not have a formalised dividend policy. The Company's Management Board adapts the dividend policy to the Company's current economic situation, taking into account the scope of necessary investments. The Company is currently in a development phase and no dividend payments are planned. In the 2025 financial year, the Company did not pay a dividend.
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Explanations of discrepancies between the actual financial results and the published forecasts
The Company did not publish financial forecasts for 2025.
- Assessment of financial resource management
As at 31 December 2025, the Company's equity had a positive value of PLN 48 828,000, whilst total debt arising from long- and short-term liabilities (trade payables and loans﴿ amounted to PLN 61 605,000.
When assessing its financing needs, the Company continuously analyses factors such as:
the value of new contracts signed with clients in the CDMO sector and further opportunities in this area;
the value of revenue that can be generated from the ongoing agreement with Novavax;
the level of the sales pipeline and the likelihood of realisation through the signing of new contracts;
the level of existing capacity in terms of services provided;
the level of operating costs incurred to ensure the ability to provide services;
the potential for securing external bridge financing;
the current and planned level of cash generated from grants, subsidies, VAT refunds and financial activities;
the current structure of financing for fixed and current assets;
the anticipated level of capital expenditure;
new subsidy or grant schemes for anticipated and ongoing projects.
In the opinion of the Company's Management Board, the management of financial resources in future periods depends on securing financing in order to be commensurate with the Company's needs and capabilities.
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Accounting principles applied to the preparation of Financial Statements
RISK AND THREAT FACTORS
In the description of risks, the extent to which the issuer is exposed to them is illustrated using the following descriptive scale:
Low risk: a risk whose materialisation will not significantly affect the Company's liquidity or the implementation of its strategy;
Medium risk: a risk requiring active monitoring; it may cause periodic disruptions or necessitate the implementation of preventive measures;
High risk: a risk that may threaten the continuity of operations or result in very significant financial losses.
In 2025, following discussions with the Supervisory Board, the Company's Management Board took steps to identify potential external sources of financing. Following the receipt of offers from selected advisors, as well as meetings regarding advisory services and support in negotiations for securing new debt, equity, or mezzanine financing from local or international investors or financial institutions, decided to proceed with a process aimed at developing an optimal financing structure that would come from the following sources (alternatively or through a combination thereof﴿:
securing debt financing, primarily from private debt funds;
raising financing through a share issuance,
securing an industry-specific or financial investor to provide additional funding to the Company.
The scenario currently being pursued is to secure bridge financing from existing investors or other interested financing entities, which, in the Management Board's assessment, is the optimal source of short-term financing until the appropriate level of financing required in the medium term is secured. The current status of the financing process is described below.
The Company's Management Board also continues to actively pursue efforts aimed at securing debt financing and is taking steps to increase capital through a share issuance. In the Management Board's assessment, these actions constitute one of the key elements in meeting the estimated capital needs.
Securing an industry or financial investor who could significantly recapitalize the Company is one of three scenarios that the Company began implementing in April 2025 with the announcement of the update to the Strategy for 2025 -2030 and continues under the new Mabion S.A. Strategy for 2025-2030 adopted in November 2025.
Work is currently underway to raise additional funds for the Company by increasing the Company's share capital through the
issuance of shares pursuant to the authorization granted to the Company's Management Board in July 2025 to issue new shares in a number not exceeding 8,081,163 Company shares (authorized capital﴿. The planned share issuance under the authorized capital will provide the Company with additional funds to secure liquidity for the coming months. This process was initiated in accordance with the resolution of the Company's Extraordinary General Meeting of July 10, 2025, and is currently underway. The planned issuance will be a private placement and will not be conducted as a public offering. The Company's Management Board believes that the risk of the recapitalization failing to materialize through an increase in the Company's share capital as a result of the share issuance is negligible; however, there is no certainty that such an issuance will take place.
Due to the complexity of the aforementioned processes and their duration, the Company requested bridge financing in the form of a loan from its shareholders.
As a result of these actions, on October 24, 2025, the Company entered into a loan agreement with Twiti Investments Ltd., under which Twiti Investments granted the Company a loan in the amount of PLN 18 million for a period of two years. On November 3, 2025, the Company received the first tranche of the loan in the amount of PLN 6 million, and on December 22, 2025, another tranche in the amount of PLN 4 million.
At the same time, recognizing the need for further external financing in the form of debt financing, on February 9, 2026 (an event after the balance sheet date﴿, the Company's Management Board entered into a loan agreement with an unrelated entity, namely ACRX Investments Limited, based in Nicosia, Cyprus, for an amount of up to PLN 6 million. The funds from this loan were made available in full on February 10, 2026. The loan was granted for a period of 6 months from the date of disbursement, and the agreement provides for the possibility of converting all or part of the loan, together with interest, into the Company's shares at any time, at the lender's request.
Subsequently, on March 13, 2026 (an event after the balance sheet date﴿, the Company entered into a loan agreement for up to EUR 3.1 million with an unrelated party, namely CBC Co., Ltd., based in Tokyo, Japan. Pursuant to the Agreement, the loan was disbursed at the Company's request in two equal tranches, with the first tranche disbursed on March 17, 2026, and the second tranche on April 22, 2026. The loan was granted for a term of 3 years from the date of disbursement, and the agreement provides for the possibility of converting all or part of the loan, together with interest, into shares of the Company at any time, at the lender's request.
In the Management Board's assessment, obtaining the above loans has enabled the Company to carry out its current operational activities and maintain its readiness and capacity to execute new contracts. The Company's Management Board assumes that bridge financing in the form of loans will provide the Company with liquidity until contracts are concluded with
new clients and funds are raised from a share issuance; however, there is no certainty of this.
In parallel with the actions described above, the Company's Management Board has taken steps to reduce operating costs and capital expenditures. This scenario supports efforts to maintain liquidity until a sufficient number of production orders are secured. This scenario is currently being pursued while taking into account the execution of operational and manufacturing processes related to the fulfillment of signed contracts, as well as the acquisition of new contracts. In the Management Board's assessment, the fulfillment of all signed contracts takes priority over potential measures aimed at drastically reducing costs, as such actions would impair the Company's operational capabilities and thereby undermine its ability to fulfill important contractual obligations.
Significant uncertainty regarding the going concern.
Despite intensive market activities, the Management Board identifies significant uncertainty regarding the ability to secure and fulfil a sufficient number of production orders that would guarantee the Company the cash flow necessary to maintain liquidity in the foreseeable future.
In addition, the Company sees a risk of potentially having to repay part or all of the grant received from NCBiR (the total grant amounts to PLN 24.9 million﴿ together with the interest due for the implementation of the project related to the MabionCD20 drug, which could significantly affect the Company's financial position. Detailed information in this regard is provided in notes 18 and 26, where the Company has addressed liquidity risk. The Management Board considers the risk of repayment to be negligible, but cannot rule it out entirely.
Consequently, there is significant uncertainty which may raise serious doubts as to the Company's ability to continue as a going concern, and for this reason the Company may not realise the expected economic benefits from its assets or settle its liabilities in the ordinary course of business. In the Management Board's opinion, the market activities currently being undertaken and the status of discussions with potential counterparties provide grounds for assuming the continued operation of the business and indicate the existence of demand for the services offered by the Company.
Despite the significant uncertainty described above, the Management Board has adopted the going concern principle as the basis for the preparation of these interim condensed financial statements. The basis for the Management Board's adoption of this principle is the support expressed by the major shareholders regarding the Company's continued implementation of its business strategy. The financial statements have been prepared in accordance with the going concern principle, which assumes that the Company will continue as a going concern for the foreseeable future, for a period of not less than 12 months from the balance sheet date. Consequently, no adjustments have been made to the interim condensed financial statements which might have been necessary had the going concern assumption not been valid.
Risk associated with the funding obtained - Low riskDuring the reporting period, in connection with completed projects still within their validity period, Mabion was a party to the following grant agreements:
1﴿ "Development and scaling of an innovative process for the manufacture of a therapeutic, recombinant monoclonal antibody, to enable the industrial implementation of the first Polish biotechnological drug for oncological and autoimmune therapies"
Project value: PLN 53,896,000 - estimated amount, PLN 49,794,000 - final project value;
Value of funding received (contribution from European Funds﴿: PLN 24,897,000;
Project implementation period: 2016-2020.
The aim of the project was to carry out development work enabling the industrial-scale production of the biotechnological drug MabionCD20 (a biosimilar to the original drug MabThera﴿. The company fulfilled the objectives, technical and quality requirements of the grant application by carrying out all the development work specified in the application. Upon completion of the project, the Company submitted the relevant documentation to the National Centre for Research and Development (NCBR﴿ and, in 2022, received notification that the NCBR had accepted the final report. However, as part of the funding received, the Company was obliged, until the end of the project's duration, to achieve the result indicators agreed with the NCBR, i.e. inter alia, to grant a licence (on market terms﴿ for the use of the Company's rights to the results of R&D work in the business activities conducted by another entrepreneur (a licence for the commercial manufacture of the drug MabionCD20﴿ and to generate revenue from this. The project duration ran until May 2025. Although the Company actively pursued activities aimed at identifying and securing a licensee, it was not possible to secure a licensee within the required timeframe. Furthermore, at the end of the project's duration, the employment rate was achieved at a slightly lower level than anticipated (this was also one of the result indicators which the Company was obliged to maintain throughout the project's duration﴿.
The Company submitted reports to the National Centre for Research and Development (NCBR﴿ on the implementation and dissemination of the project's R&D results. On March 25, 2026, it received the NCBR's assessment and decision regarding the acceptance of the Company's arguments concerning the circumstances that affected the fulfillment of the project's conditions. Based on the assessment of the Report, the NCBR deemed the implementation unfulfilled due to the market situation following the completion of the project, which had changed, making the application of the results in business operations unprofitable or significantly reducing its profitability, as well as acts of God and unforeseeable circumstances beyond the Beneficiary's control. In connection with the above, the Intermediate Body waived the demand for repayment of the grant awarded for the project's implementation.
The Company does not identify any further risks related to the implementation of the Project in question.
2﴿ "Development of a biotechnological drug through the development of an innovative IgG1 subclass monoclonal antibody with a reduced content of adverse glycoforms compared to the reference drug - directed against EGFR"
Project value: PLN 39,965,000 - estimated amount, 5,312, ,000 - final project value;
Value of co-financing (contribution from European Funds﴿: PLN 28,354,000 - estimated amount, PLN 3,912,xml-ph-0002@deepl.internal - final amount of co-financing received;
Project implementation period: 2017-2022.
In 2022, a decision was taken to discontinue the project due to the fact that, in the opinion of the Management Board, its continued implementation was not justified. In October 2022, the National Centre for Research and Development (NCBR﴿ accepted the final report on the project's implementation. In September 2025, the three-year project duration period came to an end. As at the date of publication of this Report, the Company is awaiting the assessment of the submitted report on the dissemination of the project's R&D results.
3﴿ "Development of a panel of analytical methods for characterising immunogenicity in a clinical trial targeting patients suffering from rheumatoid arthritis using rituximab as a therapeutic agent"
Project value: PLN 3,633,000 - estimated amount, PLN 1,352,000 - final project value;
Value of co-financing from the European Regional Development Fund: PLN 2,080,000 - estimated amount, PLN 918,000 - final value of co-financing;
Project implementation period: 2021-2023.
The main objective of the project was to increase research and development activity through the development and implementation of a new panel of analytical methods on a company-wide scale. As a result of the project, an innovative solution was implemented in the form of a product, i.e. a commercially provided service consisting of operating a panel of analytical methods for assessing the immunogenicity of biological products in clinical trials. In December 2024, the Business Support Centre in Łódź approved the final report on the project's implementation, and the project entered a three-year sustainability period. As at the date of publication of this Report, the Company sees no risk in maintaining the result indicator during the project's sustainability period.
All the above-mentioned grant agreements specified in detail the deadlines and scope of tasks eligible for funding. During the project sustainability period (i.e. after the completion of project work and the settlement of the project in question﴿, there are risks associated with achieving or maintaining the specific results and indicators set out in the project, or with the dissemination of results. If these are not met, there is a risk of having to repay part or all of the grant, together with statutory interest calculated from the date of payment of the relevant grant instalment. The decision regarding the necessity or amount of the grant repayment is made by the competent authority following an
individual assessment. Consequently, should the conditions giving rise to the liability materialise, the Company's financial position may deteriorate. To mitigate the above risk, the Company has internal procedures for the ongoing monitoring of project indicators, their progress and implementation schedule, and works closely with intermediary institutions, keeping them informed of potential risks at every stage of the grant agreement.
Business risk associated with the implementation of the strategy adopted by the Company - Medium riskMabion has built a solid foundation as a European GMP-certified Biotech with CDMO services, overcoming key business barriers and establishing market credibility through high quality, specialist expertise and a competitive cost structure. A key market trend is the ongoing shift from a pure CDMO model towards strategic partnerships and Co-Development to share costs, profits and risks, which Mabion has reflected in its value proposition set out in the 2025-2030 Strategy. The adopted strategic pillars will enable the Company to leverage its strengths to offer increased value through additional strategic partnerships and joint development projects. The Company continues its intensive efforts aimed at building brand recognition and credibility within the industry, as well as a competitive offering. The Company actively participated in key industry events and trade fairs to attract new clients, such as: J.P. Morgan Healthcare Conference, Biotech Showcase, Biologics World Nordics, DCAT, Bio Europe, Pharma Contract Manufacturing, CeBioForum, American Biomanufacturing Summit, CDMO Live, CPHI North America, CPHI Europe, BioProcess International, Festival of Biologics, Nordic Life Science Days, European Biomanufacturing Summit and BIO International. These activities form a key element of the development strategy, enabling direct meetings with potential clients and the presentation of the Company's capabilities and expertise. In parallel, the Company participates in webinars available on industry portals, prepares publications and other materials highlighting its offering and capabilities. The Company is also intensifying its networking activities with industry consultants, aimed at increasing brand recognition among this group, which has a real influence on the choice of a CDMO partner. Significant emphasis is also placed on expanding and building the capabilities of the Business Development Department, strengthening its team and ensuring continuous development and upskilling, in order to optimise processes aimed at client acquisition and increase the effectiveness of activities in this area. However, the risk cannot be ruled out that client acquisition may proceed in a different manner or at a slower pace than the Company currently anticipates, in terms of the schedule or type of projects, which will require flexibility and adaptability on the part of the Company. The adoption of the 2025-2030 Strategy was preceded by a thorough analysis of competencies, Mabion's accumulated experience and resources to date , as well as an analysis of market trends and market development prospects; therefore, in the Management Board's assessment, the Company is prepared for various business scenarios, whilst actively adapting its operations and service offering to be ready for different market developments. At the same time, being aware of the identified risks, the Company has adapted its Strategy and supplemented it with additional pillars
and assumptions aimed at mitigating potential deviations in the pace and structure of client acquisition. In particular, Mabion is pursuing activities aimed at finding partners for the Co-development of biological products, which enables the diversification of growth sources through cooperation that goes beyond the standard 'fee for service' model. At the same time, the Company is intensifying its efforts to acquire clients in areas related to specific types of molecules (modalities﴿ where market competition is relatively lower, whilst these areas are consistent with Mabion's existing competencies and operational capabilities. This approach enhances the business model's resilience to market volatility and increases flexibility in adapting the offering to current demand and competitive conditions
Technology risk - Medium riskOperations in the CDMO sector entail various technological risks depending on the scope and schedule of the client's order. At the research and development stage, aimed at developing the project from the cell line generation stage, the main risk relates to the productivity of the cell clone and the quality of the product obtained. The outcome of this stage of work determines the efficiency and effectiveness of the entire manufacturing process. To minimise risk in this area, the Company is in discussions with external partners who have experience in providing services relating to the development of stable cell lines, with a view to potentially outsourcing this stage to a third party. As a result of these discussions, a strategic partnership was established in 2025 with Sartorius Stedim Cellca GmbH, as discussed in more detail in section 4.4.1 of this Report. At the same time, the Company also held discussions with other partners, signing framework cooperation agreements to mitigate risk as effectively as possible, whilst maintaining the widest possible range of options for the client (section 4.4.6 of the Report﴿.
Process development projects also include formulation development,
i.e. the appropriate selection of a formulation buffer to ensure the stability of the target molecule. Mabion also carries out this stage of its projects in collaboration with an external partner, drawing on the experience and equipment resources of both parties. Mabion has finalised discussions regarding the general scope of work, which depends on the specific nature of individual projects, thereby ensuring the flexibility to adapt the detailed scope, cost and duration of the work carried out by the external entity.
The Company's activities in the area of product development from the early stages entail significant risks arising from the high level of uncertainty characteristic of research and development work. At this stage, many design assumptions are based on preliminary data, and the final form of the process, its parameters and effectiveness may change as work progresses. This risk includes, amongst other things, the possibility of having to change the development strategy, extend the timeline or adjust the scope of activities to the results obtained during the research. To minimise risk in this area, the Company has implemented a number of preventive measures. A key element is ensuring a high level of transparency towards the client - regular consultations are held at every stage of the project, during which progress, results and
potential scenarios for further action are discussed. This enables joint decision-making and a rapid response to changing project conditions. In addition, the Company has an experienced research and development team with expertise in managing projects characterised by a high degree of complexity and uncertainty. This team continuously analyses risks and proposes mitigation measures, enabling flexible project management and increasing the chances of success.
One of the key elements of the Company's offering is process transfer and the manufacture of a product meeting the client's specifications. The main technological risk in this area is the risk of failure of the actions undertaken. Mabion has successfully carried out the transfer of the vaccine antigen manufacturing process for Novavax and the product manufacturing process for NovalGen, and based on this experience has developed procedures and a protocol. Conducting the process transfer starting at the laboratory scale enables the Company to understand the process and prepare adequately for the next step, which is the transfer to commercial scale. The Company minimises the above-mentioned risk through employee training, continuous improvement of procedures, qualification of equipment and materials, as well as continuous risk monitoring. Another technological risk is the risk associated with sharing project implementation with an industry business partner. By outsourcing part of the work to a partner, the Company assumes responsibility for the overall implementation, the work schedule and the results of the tasks performed. The Company mitigates these risks thanks to its experience in outsourcing parts of process analytics and the ongoing verification of results during the contract. Project leaders oversee the execution and coordination of the project, monitoring project progress and being responsible for implementing measures to mitigate potential risks. Additionally, the Company safeguards itself with appropriate contractual provisions and has the option to change subcontractors from its extensive and proven database.
At the same time, the implementation of solutions aimed at enabling the Company's strategy for 2025-2030, such as work with bispecific antibodies (bsAbs﴿,antibody-drug conjugates (ADCs﴿ or continuous manufacturing, entails a number of additional risks. The introduction of bispecific antibody development technology presents the Company with challenges related to potential mispairing of molecules and their aggregation, which may result in reduced process yield. The implementation of antibody-drug conjugate (ADC﴿ production technology necessitates the development of methods to assess conjugate heterogeneity and linker stability, and, for specific classes of drugs, the introduction of additional measures to ensure safe handling of molecules with varying levels of toxicity. At the same time, the development of processes towards continuous manufacturing of monoclonal antibodies presents the Company with challenges regarding the maintenance of sterility in longterm cycles and the need to integrate online analytical systems (PAT﴿ for real-time monitoring of quality parameters. Ensuring the consistency of the product's glycosylation profile during the transition to perfusion systems and mitigating risks associated with scaling and technology transfer also remain key challenges in process development. The complexity of these operations dictates the need for investment in digital process modelling and
the continuous enhancement of the team's unique biotechnological expertise. All identified technological risks are subject to systematic analysis, and specific mitigation strategies are developed and implemented as part of the Company's key strategic projects.
An additional technological risk that may arise is equipment failure or malfunction, which could negatively impact the timely fulfilment of orders. To minimise this risk, maintenance and calibration activities are carried out on an ongoing basis in accordance with a schedule, and service contracts are in place for critical equipment. Mabion places great emphasis on preventive measures that support the continuous ability to carry out manufacturing (production, analytical and warehousing﴿ and development processes. The preventive action plan covers both technical installations and critical analytical and process equipment. In addition, round-the-clock monitoring is carried out of installation parameters that directly affect the production area. The Maintenance Department is working on a comprehensive prevention strategy for 2026-2028, taking into account the condition of the entire machinery fleet and aimed at identifying the areas and installations posing the greatest risks and minimising these risks through investment and other measures designed to maintain the current high level of reliability of the fleet. The prevention strategy is currently being aligned with Mabion SA's new strategy.
Risk associated with IT systems - Low riskThe implementation of the computerised LIMS system (to be completed in March 2026﴿ presents numerous challenges at every stage of the project. A key aspect is training staff to use the new system. The Company provides training for system users on how the system works and allows them to work in a test environment. The Company also identifies the risk of potential system failures. To minimise this risk, Mabion has selected proven systems that offer the highest guarantee of reliability.
Furthermore, as these are systems delivered under the SaaS (Software as a Service﴿ model, the Company has secured high levels of guaranteed service availability through the Service Level Agreement (SLA﴿ with the supplier. Another area of risk identified by the Company, which remains relevant to both systems, is the issue of cybersecurity (potential hacker attacks, phishing, DDoS attacks, etc.﴿. The Company has anti-virus and anti-spam protection in place and carries out ongoing monitoring of new, potential threats to effectively protect the Company against such threats
Risk associated with poor quality or loss of biological material - Low riskThe primary material used in Mabion's development and manufacturing processes is biological material. This is both produced in-house by the Company and supplied by external customers. The selection of optimal cell clones, which form the basis for further large-scale drug production, is of great importance in the process of developing and manufacturing biotechnological drugs for clients. The key factor determining the success of the work is the quality of the biological material and its storage under strictly defined conditions. There is a risk that biological material obtained from a client or supplier, or produced by the
Company, may be of poor quality or may be damaged or destroyed, which could consequently have a negative impact on the achievement of the Company's planned revenues and financial results. With regard to biological material received from a client, the Company verifies the transport conditions and other parameters specific to the material in question prior to acceptance. Confirmation of compliance with internal procedures enables the material to be admitted to the production or laboratory area and further work to be carried out on it. The Company safeguards the processes for obtaining material of the appropriate quality within its operations through proper preparation of the process and product in the development phase. It is necessary to optimise the processes for obtaining recombinant proteins in cell culture and their purification, thereby ensuring that the conditions at these stages of the process allow for the production of a product of the appropriate quality and purity. Each comprehensive optimisation of the aforementioned stages is lengthy and time-consuming, which creates a risk of being unable to secure a client for the described activities. To minimise this risk, the Company has developed a platform-based approach to optimising the stages of the cell culture and purification process. Thanks to the research carried out, the described stages will be able to be completed in a significantly shorter time and at a lower cost, whilst ensuring the reproducibility of the processes. The platform-based approach, utilising the Company's technological solutions at both laboratory and manufacturing scales, also significantly reduces the risk of failure and/or unexpected results during the scaling of subsequent processes, thereby minimising the risk of low quality or loss of biological material. The Company collaborates exclusively with market-proven suppliers, monitors the quality of deliveries and stores biological material in dedicated equipment, utilising monitoring systems and two independent power sources.
Risks associated with the quality control process - Low riskOne of the key elements of biotechnology drug manufacturing is the production process, which must be conducted in accordance with predefined parameters. The production process for such drugs consists of several stages, and even the slightest deviation (outside the specified range of a given parameter﴿ in any of them may adversely affect the drug's properties (e.g. in terms of efficacy or safety﴿. It is vital to ensure continuity, including product quality control at intermediate and final stages, stability testing, and purity monitoring throughout the entire manufacturing process. The Quality Control Laboratories are equipped with apparatus meeting the highest standards of the nd pharmaceutical regulations. A panel of appropriate validated analytical methods ensures maximum accuracy, precision, specificity and reproducibility of the results obtained. The Quality Control team has the experience and expertise to design and validate, or transfer from the client, an appropriate analytical panel in accordance with regulatory requirements and guidelines, enabling reliable product control. A key aspect of analytical methods is the control strategy for the analytical procedure, which should ensure that the analytical procedure performs as expected throughout its entire lifecycle. Continuous monitoring of the method over time is critical for studies in which results are collected over several years (e.g. product stability, quality studies﴿. The absence of a robust strategy, including trend analysis, may adversely affect the final assessment
of both production processes and the products themselves. The management of the Company's departments consists of high-ranking specialists with relevant academic qualifications, who have been trained and adequately prepared to carry out their duties by both internal and external experts. The Company holds the necessary authorisations (including the GMP Certificate for the Complex in Konstantynów Łódzki issued by the Chief Pharmaceutical Inspector﴿, which ensures that quality control staff undergo continuous professional development, training and keep abreast of changes in guidelines regarding process and product control within the framework of sterile drug manufacturing, and operate in full readiness in accordance with applicable system procedures.
Risk associated with the manufacturing process in the provision of CDMO services - Low riskThe manufacturing process is continuously monitored and verified in accordance with the Company's established procedures, enabling the Company to systematically strive to reduce the level of risk in this area. The Company holds the necessary authorisations (including the Authorisation for the Manufacture or Import of a Medicinal Product - MIA - issued by the Chief Pharmaceutical Inspector for the Complex in Konstantynów Łódzki﴿.
Risk associated with employment at the Company - High riskMabion operates on the basis of the knowledge and experience of its highly qualified management and research staff. There is a risk that the Company may lose key personnel in the future, which could have a negative impact on the quality and scope of the services it offers. The Company may also be unable to recruit or retain qualified personnel due to the intense competition for such staff among biotechnology, pharmaceutical and other related companies. If the Company is unable to attract, retain and motivate key personnel to achieve its business objectives, it may face constraints that seriously hinder the implementation of its business strategy. The Company's results depend in part on maintaining an appropriate staffing level, as well as on the ability to effectively integrate newly recruited senior management into the existing management team and on the ability to foster effective working relationships amongst senior management. To mitigate this risk, the Company's Management Board pursues an active human resources policy aimed at recruiting and retaining the most valuable specialists and leaders within the company, as well as supporting their development. The Company's success depends, among other things, on its ongoing ability to recruit, retain and motivate highly qualified management, research and specialist staff. The Company's Management Board monitors trends in the remuneration market, including non-wage benefits, and implements new solutions within the Company on an ongoing basis. The Company must also ensure that teams' skills are continuously updated to prepare them for the effective use of new equipment and technologies and to ensure operational efficiency. It is crucial to reduce employee turnover, ensure succession planning, and nurture talent; for this reason, among others, the Company joined the Economic Council of the Łódź Province in July 2025, committing to initiatives that support the region's development, including those related to strategic specializations.
Risk associated with the possibility of disclosure of trade secrets - Low riskThe implementation of the Company's plans may depend on the preservation of confidential information held by the Company, in particular information concerning ongoing projects and the technological processes associated with them. It cannot be ruled out that this information may be disclosed and used by persons or entities cooperating with the Company. To protect itself against the negative consequences of such events, including potential claims from customers, the Company has taken a number of legal steps aimed at minimising this risk. As part of induction training, sessions on intellectual property protection are conducted, and refresher training is organised for the team at the start of a project to ensure they are up to date with the customer's IP protection requirements. In addition, the Company employs various IT security measures, such as encrypting laptop hard drives. It also uses multi-factor authentication when logging into devices, and access to company resources from outside the Company's premises is only possible after connecting via VPN and passing multi-factor authentication.
Risks related to the macroeconomic, legal and political environment - Medium riskAny adverse changes in the macroeconomic, legal or geo-political environment, such as a slowdown in economic growth or a reduction in healthcare spending, may have a negative impact on the Company's operations and financial results. Significant economic factors affecting the Company's financial results include: GDP levels, average wage levels, unemployment rates, inflation rates, healthcare expenditure levels, and rapid legislative changes adversely affecting legal certainty. The rising level of inflation in recent years has affected the prices of a range of goods purchased by the Company, as well as energy prices and the interest rates on the Company's leases. Domestic and foreign laws and regulations governing the Company's operations necessitate the adaptation of the Company's internal rules and procedures to legislative requirements. Failure to comply with applicable regulations may result in the imposition of financial penalties or other sanctions on the Company. The Management Board monitors the macroeconomic, legal and geo-political situation on an ongoing basis and considering impact of regional conflicts, endeavouring to adapt the Company's strategy and procedures to changes in these areas well in advance. The current geopolitical and macroeconomic situation, linked, amongst other things, to tariff policy, is causing significant uncertainty and may influence business decisions regarding investments or the selection of a CDMO in terms of location relative to the target market for a given product. The Company's Management Board continuously analyses regulations introduced by the Polish Government, the governments of other EU countries and the United States, in order to minimise business risk in this regard and adapt to changing conditions by appropriately tailoring and targeting its offering.
Force majeure risk - Medium riskIn the event of unforeseeable events, such as wars, terrorist attacks or epidemics, there may be adverse changes in the economic climate and financial markets, which could negatively impact the
Company's financial position and/or the schedules of projects being carried out by the Company. Furthermore, random events such as fires, floods and other extraordinary acts of nature may cause breakdowns or damage to significant tangible assets belonging to Mabion, as well as disruptions to its operations, which may adversely affect the Company's financial results. The economic situation in the East, in connection with the war in Ukraine, has made the macroeconomic environment less predictable, which may result in further price increases (e.g. for energy﴿, the introduction of restrictions on free trade or other business restrictions, including disruptions to the supply chain for goods and services. The risk of a possible escalation of the conflict to neighbouring countries, including Poland, cyberattacks on IT infrastructure, or a reduction in investment levels in Poland due to uncertainty among foreign investors cannot be ruled out. The Company has analysed the impact of the ongoing Russian-Ukrainian conflict and its current and potential future effects on the Company. In the Company's assessment, the invasion and its associated effects do not affect the valuation and classification of assets and liabilities in the financial statements as at 31 December 2025, nor do they directly affect the Company's operating activities as at the date of publication of this Report.
Risks associated with conducting business on an international scale - Medium riskOperating on an international scale entails a number of risks, including, amongst others: diverse, conflicting and changing laws and regulations, including those relating to privacy, taxes, export and import restrictions, labour laws, regulatory requirements and other administrative consents, permits and authorisations; the failure of entities cooperating with the Company to obtain or maintain regulatory approvals in various countries for the use of products manufactured by the Company;
additional potentially significant third-party patent rights;
the complex and difficult aspects of obtaining protection for and enforcing intellectual property rights;
the risk of difficulties in expanding the Company's operations in the US, Canada and South American markets due to regulations that are distinct and different from those in force within the EU;
financial risks such as long payment cycles, difficulties in debt collection, the impact of local and regional financial crises on demand and on payment for products, as well as exposure to exchange rate fluctuations;
natural disasters, political and economic instability, including war, terrorism, civil unrest, disease outbreaks, boycotts, restrictions on free trade and other business restrictions;
regulatory and compliance risks, which relate, amongst other things, to ensuring the reliability of information and control over sales and operations.
The Company's Management Board monitors risks associated with conducting business on an international scale on an ongoing basis, endeavouring to adapt the Company's strategy and procedures to potential changes in the business environment well in advance.
Risk associated with changes in legislation and its interpretation - Low riskThe frequent changes in legislation characteristic of the Polish legal system may pose a risk to the Company, which could render forecasts regarding its business operations obsolete and cause its financial condition to deteriorate. The regulations whose changes have the greatest impact on the Company's operations include, in particular, tax and labour law, legislation governing the social security system and publicly funded healthcare, as well as pharmaceutical and intellectual property law. Changes to the above regulations may lead to a significant change in the Company's legal environment and affect its financial results. A significant factor that may affect the Company's development prospects, financial performance and financial position is also the divergence in the interpretation of the legal order in force in Poland and the European Union. The lack of uniformity in the interpretation of regulations by national courts and public administration bodies, as well as by EU courts, may lead to consequences affecting the Company both directly and indirectly. The Management Board monitors on an ongoing basis changes to legal provisions that are key from the Company's perspective and the manner in which they are interpreted, consulting external experts in this area as well, so as to adapt the Company's strategy to such changes well in advance.
Risk related to tax policy - Low riskOne of the main factors influencing business decisions is Polish tax law, which is characterised by frequent changes and a lack of precision in the provisions that make it up, which often lack a uniform interpretation. Both the practice of tax authorities and court rulings on tax matters, based on ambiguous legal regulations, result in increased business risk in Poland compared to the more stable tax systems of countries with mature economies. A process of harmonising tax regulations is gradually taking place, ensuring their unambiguous interpretation by businesses and tax authorities. The Company monitors changes in tax legislation, collaborates with reputable advisers and, where justified, applies to the relevant authorities for interpretations.
Risk associated with administrative decisions (including those of regulatory agencies﴿ - Low riskThe Company cannot guarantee that, despite exercising due diligence on its part, the specific licences, permits and consents required for the implementation of biotechnology projects, including those related to environmental protection, will be obtained by the Company within the anticipated timeframes, or that any current or future licences, permits or consents will not be revoked. Such situations may result in delays in implementation or changes to the original projects and adversely affect the
Company's operations and financial results. The risk indicated above relates mainly to aspects associated with commercial projects carried out for entities located outside the jurisdiction of European regulatory agencies (e.g. the USA﴿. For these areas, it may be necessary to carry out inspections in fields where the Company has no prior inspection experience, and preparing the facility to comply with other legal regulations may require a significant investment of time.
Any change in the scope and type of services provided (including manufacturing﴿ necessitates a review of the scope of existing permits (including environmental and pharmaceutical permits﴿ and may potentially have a negative impact on the schedules planned by the Company. To mitigate this risk, the Company employs specialists within its structure in both the area of pharmaceutical regulations and other legal areas within which the Company fulfils its responsibilities.
Currency risk - Low riskSome of the raw materials necessary for production are purchased in a foreign currency or denominated in Polish zlotys on the transaction date (US dollars and euros﴿. The Company may also make significant capital purchases related to the retrofitting of the plant, where the contract currency is the euro or the US dollar. The costs of consultancy services purchased by the Company, denominated in foreign currencies and provided in subsequent reporting periods, may also generate currency risk. Adverse changes in exchange rates (a weakening of the zloty against foreign currencies﴿ may lead to an increase in the Company's capital expenditure and current costs, which may have a negative impact on the Company's financial results. The Company currently does not use hedging instruments to mitigate the impact of changes resulting from temporary fluctuations in exchange rates on the Company's financial results and capital position. It is expected that the risk associated with exchange rate fluctuations arising from liabilities incurred will be mitigated through natural hedging by the Company providing services in foreign currencies. The Company is actively seeking customers in foreign markets, the acquisition of whom will allow for a further reduction in any potential adverse effects of exchange rate risk. It cannot be ruled out that the Company may incur exchange rate differences resulting from fluctuations in exchange rates due to a difference in the timing of the recognition of receivables or liabilities and the settlement of payments denominated in a foreign currency, including as a result of the conversion of received funds into Polish zlotys. The Company regularly analyses the level of currency risk and the potential impact of the above changes on the results for the period.
Competition risk - Medium riskMabion offers a wide range of services to other companies at various stages of development, focusing on medicines produced using mammalian cells, including process development, the manufacture of active pharmaceutical ingredients and finished products, as well as a broad range of analytical methods, whilst offering a flexible approach to clients, time efficiency and a
competitive range of services and prices. The expertise developed in drug development also enables support for earlier stages of development (from pre-GMP manufacturing to clinical trials or commercialisation﴿, as well as a thorough characterisation of the active substance and the medicinal product, which are intrinsically linked to drug development and regulatory processes, and technical and strategic consultancy at all stages of development. However, the risk cannot be ruled out that competition in the CDMO market will require the Company to build new competitive advantages. According to a report by L.E.K. prepared for Mabion in 2021, the choice of a CDMO is primarily determined by aspects such as the entity's quality, reliability and operational efficiency. These findings were confirmed by the 2023 Industry Standard Research report, which further emphasised the importance of a 'track record' demonstrating that the CDMO has delivered contracts on schedule, has available production capacity, and maintains engagement with regulatory agencies such as the EMA and FDA. The company develops its offering with an awareness of what plays a key role for potential clients. An additional competitive advantage for Mabion may also lie in establishing strategic relationships (partnerships﴿ with entities that are leaders in the CDMO/CRO market within selected service segments. Many of these companies focus on specific areas of activity and do not offer a full range of services, which creates an opportunity for Mabion as a natural partner that can take over the implementation of projects at subsequent stages. Such synergies will not only allow for the expansion of the customer base and an increase in the scope of services offered, but also for the strengthening of Mabion's position as a flexible and comprehensive provider of biopharmaceutical services.
Risk associated with the performance of contracts - Medium riskThe Company carries out contract projects based on a schedule agreed with the client and the provisions set out in the contract. Remuneration for the completion of individual project stages depends on their completion within specified deadlines. However, it should be noted that during the course of the project - as a result of the work carried out and ongoing consultations with the partner - there may be grounds for modifying the original contractual assumptions, including those relating to the production process or ancillary activities. Such changes may affect the deadlines specified in the schedule. In order to mitigate the risk associated with the timely fulfilment of contractual obligations, the Company has established a Project Management Department within its organisational structure. Each project is supervised by a dedicated manager who regularly monitors progress using IT tools. These systems enable real-time tracking of project implementation and the early identification of potential risks that may affect compliance with the agreed schedule. For projects carried out in cooperation with external partners, the Company ensures comprehensive coordination of activities, ensuring the consistency and integrity of the service provided. Additionally, risks associated with partnerships are mitigated through appropriate contractual provisions and flexibility in the selection of subcontractors, thanks to a broad and proven database of cooperating entities.
Risks related to the supply chain for materials and transport - Low riskOperating in a dynamic market environment, the Company may face challenges related to the availability and quality of materials. Potential risks include delays in the supply of key raw materials, fluctuations in the quality of supplied materials, and global disruptions in supply chains. In the case of single-use technologies, such as disposable bags, the Company relies on specialised solutions, which may affect production processes. Additionally, variations in the quality of raw materials may impact the final product, which is why close monitoring and supervision of suppliers is so important. Despite these potential challenges, the Company effectively manages its supply chain, ensuring stability and continuity of production through a carefully selected supplier diversification strategy. All materials used in the production area hold the required certifications, meeting the highest standards of the pharmaceutical industry ( ﴿. The Company actively collaborates with suppliers at both global and local levels, giving preference to entities operating in Poland and the European Union. This ensures timely deliveries and high quality of key raw materials, which translates into the efficiency of production planning processes. The strategy of supplier diversification and maintaining safety stocks has enabled the Company to respond effectively to global challenges, as confirmed by the experience gained during the pandemic. During this difficult period, the Company successfully implemented projects, adapting supply chains to changing market conditions and ensuring production continuity in accordance with the planned schedules. In addition, the Company conducts systematic supervision of suppliers, including qualification processes and audits, which ensures that materials and services comply with GMP standards. Thanks to an effectively implemented strategy and appropriate risk management, the Company is well prepared for further growth and for supplying products to global markets.
Risk related to disputes concerning industrial and intellectual property rights - Low riskThe Company operates in a sector where regulations concerning industrial and intellectual property rights and their protection are of significant importance. The Company intends to conduct its
business in such a way as not to infringe the industrial and intellectual property rights of third parties, ensuring appropriate provisions in contracts with customers. However, it cannot be ruled out that third parties may bring claims against the Company alleging infringement of industrial and intellectual property rights. The raising of such claims, even if they are unfounded, may adversely affect the time required to carry out relevant operational or business activities, and defending against such claims and any legal disputes may entail significant costs, which in turn may negatively impact the Company's financial results. To the best of the Company's knowledge, there are currently no proceedings pending against it relating to the infringement of industrial and intellectual property rights.
Risk associated with operations in the Łódź Special Economic Zone - Low riskThe company operates in the service sector and has built a fully equipped research and industrial complex within the Łódź Special Economic Zone (ŁSSE﴿. Under the Act on Special Economic Zones, income derived from business activities conducted within a special economic zone, under the terms of the permit granted, is exempt from corporation tax. Mabion retains the right to this exemption until 31 December 2026. There is a risk that changes may occur in the law governing the operation of special economic zones or the tax preferences applicable within them. Should the Company's permit expire, Mabion S.A.'s operations within the ŁSSE may cease to be advantageous and increase the tax burden.
Risk associated with the political and economic situation in the Middle East - Low riskThe Company's Management Board assesses the direct impact of the current situation in the Middle East on the day-to-day operations of Mabion S.A. as low. The Company has no significant assets or direct business partners in the conflict-affected region. Potential indirect risks, including increases in air freight costs and volatility in energy prices, are subject to ongoing monitoring and analysis. The Company's supply chain is concentrated in European countries, which allows for full safeguarding of the continuity of ongoing processes and the timely delivery of projects for existing clients.
