General and administrative expenses consist primarily of professional fees such as legal, auditing, tax and business consulting services, personnel expenses and travel costs, costs associated with being a publicly traded company such as Sarbanes-Oxley compliance, accounting fees, and directors’ and officers’ liability insurance premiums.

filing / Aug 12, 2026 / receipt

If a prolonged government shutdown or other disruption occurs, including due to government shutdowns, furloughs, budget constraints, travel restrictions, staffing shortages, or if global health or other concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities in a timely manner, it could significantly impact the ability of

filing / Aug 12, 2026 / receipt

Further, under the current administration, agency reorganization, departure of high-profile regulators at the FDA, layoffs due to the reduction in force initiative, government shutdown, and a lapse of U.S.

filing / Aug 12, 2026 / receipt

The increase was primarily due to an increase of $12.0 million in manufacturing and clinical expenses related to FB102 for our Phase 2 clinical trial for celiac disease and Phase 1b clinical trials for vitiligo and alopecia areata, and an increase of $1.4 million in personnel-related expenses due to an increase in headcount.

filing / Aug 12, 2026 / receipt

The increase was primarily due to an increase of $16.3 million in manufacturing and clinical expenses related to FB102 for our Phase 2 clinical trial for celiac disease and Phase 1b clinical trials for vitiligo and alopecia areata, an increase of $2.3 million in preclinical expenses, and an increase of $2.9 million in personnel-related expenses due to an increase in headcount.

filing / Aug 12, 2026 / receipt

agency changes lead to disruptions in FDA’s operations, including changes resulting from executive orders; freeze on hiring, federal funding for research, and external communications; layoffs; government shutdowns; return-to-office policies; and changes in funding for certain programs at the FDA, correspondence and regulatory review processes with the FDA may be materially delayed.

filing / Aug 12, 2026 / receipt

General and administrative expenses consist primarily of professional fees such as legal, auditing, tax and business consulting services, personnel expenses and travel costs, costs associated with being a publicly traded company such as Sarbanes-Oxley compliance, accounting fees, and directors’ and officers’ liability insurance premiums.

filing / May 11, 2026 / receipt

If a prolonged government shutdown or other disruption occurs, including due to government shutdowns, furloughs, budget constraints, travel restrictions, staffing shortages, or if global health or other concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities in a timely manner, it could significantly impact the ability of

filing / May 11, 2026 / receipt

Further, under the current administration, agency reorganization, departure of high-profile regulators at the FDA, layoffs due to the reduction in force initiative, government shutdown, and a lapse of U.S.

filing / May 11, 2026 / receipt

changes lead to disruptions in FDA’s operations, including changes resulting from executive orders; freeze on hiring, federal funding for research, and external communications; layoffs; government shutdowns; return-to-office policies; and changes in funding for certain programs at the FDA, correspondence and regulatory review processes with the FDA may be materially delayed.

filing / May 11, 2026 / receipt