Risks Related to Our Financial Position and Need for Additional Capital

Biotechnology market

We are a global biotechnology company with limited sales experience, limited historical profit from product sales and limited historical data on product revenues. Except for the commercial launch of filgotinib, which business we transferred to Alfasigma in January 2024, our operations have been limited to developing our technology and undertaking preclinical studies and clinical trials of our product candidates.

In October 2025, after considering all available options, we announced our intention to wind down our cell therapy activities, which was subject to the conclusion of consultations with works councils in Belgium and the Netherlands. Following completion of the works council processes in Belgium and the Netherlands, our Board of Directors announced in January 2026 its decision to initiate the wind-down of our cell therapy activities, which is expected to be substantially completed by the en of the third quarter of 2026. As part of a strategic transformation of our Company, we determined to focus on transformational business development transactions and have adjusted our pipeline prioritization strategy and resource allocation in order to enable the acquisition, partnering, or licensing of product candidates that we believe to have commercial potential. We expect to devote substantial time and resources to exploring strategic transactions that our Board of Directors believes will maximize shareholder value. Because we have only recently adopted this strategy and have limited ongoing operations, we have a constrained basis to evaluate our business or forecast future operating results.

Significant operating losses

Since our inception, and with the exception of the years 2019, 2023, 2024, and 2025, we have incurred significant operating losses. Our losses resulted principally from costs incurred in R&D, preclinical testing, clinical development of our product candidates as well as costs incurred for research programs, (pre-)commercial activities, primarily related to the commercial launch of Jyseleca®, and from general and administrative costs associated with our operations. We expect to continue incurring significant research, development and other expenses related to our ongoing operations, and given the 2025 recognition of the full amount of the deferred revenue liability related to the OLCA, going forward we expect to incur operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with pharmaceutical product development and business development, we are unable to predict the timing or amount of expenses and when we will be able to achieve or maintain profitability, if ever.

Substantial additional funding may be required

We may require substantial additional future capital which may not be available to us on acceptable terms, or at all, in order to perform business development, including acquiring product candidates, and complete clinical development and, if we are successful, to commercialize any of our current or future product candidates, if approved. Because successful development of product candidates is uncertain, we are unable to estimate the actual funds and resources we will require to complete business development transactions, R&D and commercialize our product candidates. Our ability to raise additional funds will depend on financial, economic and market conditions and other factors, over which we may have no or limited control. In addition, raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our current or future product candidates or technologies. The incurrence of additional indebtedness could result in increased fixed payment obligations and could also result in certain additional restrictive covenants that could adversely impact our ability to conduct our business.

For further reference on financial risks in particular, see note 35 of the notes to the consolidated financial statements.