(1) Management is continuing to evaluate options to optimize its real estate footprint, which includes the potential amendment of a facility lease to reduce square footage.

filing / Aug 10, 2026 / receipt

The United States government, state legislatures, and foreign governmental entities have shown significant interest in implementing cost containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and coverage, drug importation programs and proposals, and requirements for substitution of generic products for branded prescription drugs.

filing / Aug 10, 2026 / receipt

In addition to continuing pressure on prices and cost containment measures, legislative developments at the EU or member state level may result in significant additional requirements or obstacles that may increase our operating costs.

filing / Aug 10, 2026 / receipt

For example, as described elsewhere in these Risk Factors, we have conducted several portfolio prioritizations and associated workforce reductions in order to focus and consolidate our resources.

filing / Aug 10, 2026 / receipt

trials and related activities, and to monitor and manage data for our ongoing preclinical and clinical programs, and we have relied to a greater extent on such outsourced activities following our November 2024 workforce reduction.

filing / Aug 10, 2026 / receipt

budget and funding levels, changes in federal agency leadership, statutory, regulatory, and other governmental changes, including government administration policy actions, such as those relating to hiring and return-to-office and reduction-in-force initiatives, the FDA’s ability to hire and retain key personnel, including personnel with the expertise necessary to evaluate product candidates such as ours, and accept t

filing / Aug 10, 2026 / receipt

The United States government, state legislatures, and foreign governmental entities have shown significant interest in implementing cost containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and coverage, drug importation programs and proposals, and requirements for substitution of generic products for branded prescription drugs.

filing / May 11, 2026 / receipt

In addition to continuing pressure on prices and cost containment measures, legislative developments at the EU or member state level may result in significant additional requirements or obstacles that may increase our operating costs.

filing / May 11, 2026 / receipt

For example, as described elsewhere in these Risk Factors, we have conducted several portfolio prioritizations and associated workforce reductions in order to focus and consolidate our resources.

filing / May 11, 2026 / receipt

trials and related activities, and to monitor and manage data for our ongoing preclinical and clinical programs, and we have relied to a greater extent on such outsourced activities following our November 2024 workforce reduction.

filing / May 11, 2026 / receipt

budget and funding levels, changes in federal agency leadership, statutory, regulatory, and other governmental changes, including government administration policy actions, such as those relating to hiring and return-to-office, and policies implemented by the Department of Government Efficiency, including reduction-in-force initiatives, the FDA’s ability to hire and retain key personnel, including personnel with the e

filing / May 11, 2026 / receipt