In June 2026, we terminated the lease for the GMMC Facility, which we decommissioned in 2025 to reduce costs. Notwithstanding the closure of the GMMC Facility, we have retained our internal process and assay development know-how and plan to transfer our AAV manufacturing process to a contract development manufacturing organization with global capabilities in anticipation of future late-stage development and/or commer

filing / Aug 5, 2026 / receipt

• a $3.3 million decrease in research expenses, reflecting lower employee-related costs driven by the workforce reduction implemented in March 2025 (the 2025 Workforce Reduction) and reduced lab supply and service costs; and

filing / Aug 5, 2026 / receipt

• a decrease of $2.2 million in manufacturing costs reflecting lower employee-related costs driven by the 2025 Workforce Reduction and lower facility maintenance fees and depreciation expense.

filing / Aug 5, 2026 / receipt

The implementation of cost containment measures, including the prescription drug provisions under the IRA, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.

filing / Aug 5, 2026 / receipt

• the practical and financial burden of the trial protocol on patients, including conflicts with their work, family and personal activities, as well as travel costs, lodging, lost wages and insufficient reimbursement or support;

filing / Aug 5, 2026 / receipt

Further, changes to the leadership of federal agencies under the current administration, as well as new policies, executive orders and actions, such as a freeze on hiring, return-to-office policy, and a freeze on implementing new regulations and on external communications, may impact normal operations of the FDA and other agencies or result in a material impact on our clinical development plans and timelines.

filing / Aug 5, 2026 / receipt

The year-over-year decrease of $1.0 million, or 16%, was primarily due to decreases in employee-related costs driven by the 2025 Workforce Reduction and lower professional fees.

filing / May 6, 2026 / receipt

• a $3.0 million decrease in research expenses, reflecting lower employee-related costs driven by the workforce reduction implemented in March 2025 (the 2025 Workforce Reduction) and reduced lab supply and service costs; and

filing / May 6, 2026 / receipt

The implementation of cost containment measures, including the prescription drug provisions under the IRA, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.

filing / May 6, 2026 / receipt

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our product candidates.

filing / May 6, 2026 / receipt

• the practical and financial burden of the trial protocol on patients, including conflicts with their work, family and personal activities, as well as travel costs, lodging, lost wages and insufficient reimbursement or support;

filing / May 6, 2026 / receipt

Further, changes to the leadership of federal agencies under the current administration, as well as new policies, executive orders and actions, such as a freeze on hiring, return-to-office policy, and a freeze on implementing new regulations and on external

filing / May 6, 2026 / receipt