Risks Related to Our Business Development Strategy
Our corporate transformation, including wind-down of cell therapy activities
Due to our limited resources, as well as the depth and breadth of our portfolio, we assess and prioritize our programs on an ongoing basis based on various factors, including internal and external opportunities and constraints, which may result in our decision to advance certain programs ahead or instead of others, or to divest or wind down certain programs. In 2025, as part of a strategic transformation of our Company, we determined to focus on strategic 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.
As part of such strategic transformation, we appointed new members to our senior management and Board of Directors with experience and expertise in business development, and our Board of Directors initiated a wind-down of our cell therapy activities. As a result, we are exiting the cell therapy space, which impacts approximately 365 employees across Europe, the United States and China, and which results in the closure of our sites in Leiden (the Netherlands), Basel (Switzerland), Princeton and Pittsburgh (U.S.), and Shanghai (China).
The transformation may not deliver expected benefits or savings and may disrupt operations. Portfolio narrowing increases risk concentration. Divestitures may be difficult to execute, dilutive, or delayed, may involve challenges, loss of personnel, contingent liabilities and impairment charges, and we may not achieve objectives. Furthermore, the wind-down of our cell therapy activities is subject to various risks and uncertainties and the related workforce reduction could yield unanticipated consequences, such as increased difficulties in implementing our business strategy, including retention of our remaining employees, and may not be completed in a timely manner on terms favorable to us, or at all. Delays, higher‑than‑expected costs, or less favorable execution could adversely affect our operations, financial position, and cash flows. The wind‑down could also prompt negative publicity, reduce investor confidence, or lead to litigation.
Our corporate transformation, including our pipeline prioritization efforts, may not be successful and may not yield the desired results, which could harm our reputation and increase share price volatility.
Business development transactions can result in integration difficulties, or may not realize the intended advantages
Despite our significant efforts to identify and evaluate potential strategic transactions, there is no assurance that any transaction will be pursued or completed on acceptable terms. The process is costly, time‑consuming, and complex. We have incurred, and may continue to incur significant legal, accounting and related expenses, including unforeseen costs, regardless of whether a transaction is completed. These expenses reduce the cash available for our operations. Our limited resources and the increasing competition in the biopharmaceutical sector may hinder our ability to secure attractive opportunities or may increase transaction costs.
As part of our efforts to acquire companies, business or product candidates or to enter into other significant transactions, we conduct business, legal, and financial due diligence with the goal of identifying and evaluating material risks involved in the transaction. Despite our efforts, we ultimately may be unsuccessful in ascertaining or evaluating all regulatory, antitrust, integration, tax, and other risks. Strategic transactions may involve significant cash outflows, liabilities, or losses. Even if we successfully consummate a strategic transaction, we may fail to realize the intended benefits of the transaction, such benefits may take longer to realize than expected, or we may not be able to operate any acquired business profitably. We may encounter integration difficulties, including retaining key personnel needed to advance acquired product candidates, and any of such difficulties could adversely affect our share price, operating results, and overall operations. Integrating any newly acquired business could be expensive and time-consuming. Integration efforts often take a significant amount of time, place a significant strain on managerial, operational and financial resources, result in loss of key personnel and could prove to be more difficult or expensive than we predict. Failure to effectively manage these risks could negatively affect our profitability and operations.
The future success and growth of our business will likely be dependent on the execution of our business development strategy and on the approval and commercialization of acquired or licensed product candidates. Given the uncertainty inherent in drug development, failure to obtain regulatory approval for a sufficient number of candidates could undermine our business model and, in turn, have a material adverse effect on our business, financial condition and results of operations.
We also refer to the section “Dependent on our ability to negotiate amended terms of the OLCA with Gilead to consummate a business development transaction”. Any Gilead‑partnered transaction will be subject to the same risks as our existing collaboration with Gilead. Our interests may diverge, and we may be unable to steer the collaboration as we consider appropriate, which could expose us to additional risks.