Labcorp

• The planned Phase 1 Part 3 dose-expansion and Phase 2 portions were not conducted because of early trial termination.

These findings describe the trial, not the service provider’s performance or responsibility.

• The study enrolled 9 participants across France, Israel, Italy, and the Republic of Korea.
• A May 2022 amendment changed the design from a single-arm two-stage study to a single-arm study with two interim analyses.
• Eligibility criteria were updated in amendments dated May 2022 and March 2023.
• A March 2023 amendment updated definitions for time to first deterioration in cough, pain, dyspnea, and physical functioning.
• Paper diary cards were added for sites in China in a March 2023 amendment.

These findings describe the trial, not the service provider’s performance or responsibility.

• The trial had no global interruptions.
• The two independent studies used a common screening platform, and entry into the remission-withdrawal period was optional.
• COVID-19 logistical restrictions accounted for one open-label Study 1 non-completion.
• Geopolitical restrictions accounted for four open-label Study 1 and one open-label Study 2 non-completions.
• A global amendment removed the Japan substudy from Study 1 and revised the number of participating countries to approximately 25.
• MRI eligibility was clarified, and participants with MRI contraindications were excluded.

These findings describe the trial, not the service provider’s performance or responsibility.

• The study enrolled 451 participants at 120 investigative sites in 24 countries from 24 April 2018 to 31 December 2025.
• Because of an unexpected slowing of the EFS rate, the pre-planned second interim IRF-EFS analysis was converted to the final IRF-EFS analysis, with longer follow-up than originally planned.

These findings describe the trial, not the service provider’s performance or responsibility.

• The trial enrolled 35 healthy subjects at one investigative site in the Netherlands between 18 October 2023 and 28 March 2024.
• All subjects in the 1500 mg/Q12h cohort discontinued before Day 10, precluding Day 10 pharmacokinetic assessments for this cohort.
• A protocol amendment added ultrasound inspection at follow-up after PICC-line removal to monitor safety and well-being.

These findings describe the trial, not the service provider’s performance or responsibility.

• Approximately 50% of the first 22 Part 1 participants experienced on-treatment ALT elevations, and protocol management criteria were amended because some elevations were prolonged.
• New enrollment was temporarily halted in December 2022 after significant ALT elevations were observed more frequently in Part 2 participants with screening or baseline HBsAg >10,000 IU/mL.
• Enrollment was not reopened because the sponsor discontinued further investment in its hepatitis B and D discovery and development programs.
• Part 2 open-label treatment was reduced to Week 96 and follow-up to 24 weeks under protocol amendment 5.
• Sustained HBV response was not collected or analyzed because follow-up was shortened and participants continued NA treatment during follow-up.

These findings describe the trial, not the service provider’s performance or responsibility.