Theralase(R) Completes Enrollment in Bladder Cancer Clinical Study

Executive Summary

• Theralase® Technologies announced successful completion of its targeted enrollment and treatment of 90 patients in a multi‑center Phase II study for BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC).
• The milestone fulfills the statistical analysis plan, positioning the company to compile data and seek Health Canada and FDA regulatory approvals in 2026.
• Management highlighted that the trial’s efficacy, duration of response, and safety data are strong, supporting a potential bladder‑sparing treatment option.

Key Details

• Study Completion: Enrollment and treatment of 90 NMIBC CIS patients across 12 sites in Canada and the United States.
• Primary Endpoint: Efficacy; Secondary: Duration of response; Tertiary: Safety.
• Therapeutic Agent: Light‑activated Ruvidar® administered via the TLC‑3200 Medical Laser System.
• Regulatory Outlook: Data to be compiled for Health Canada and FDA submissions; pending approvals could enable a transformative bladder‑sparing therapy.
• Clinical Results (to date): Demonstrated strong efficacy, durable responses with a single treatment, and a favorable safety profile.
• Future Plans (2026): Complete Phase II data compilation, initiate combinational bladder cancer study, and launch multiple Phase I/II adaptive studies for brain, lung, muscle‑invasive bladder, pancreatic, and colorectal cancers.

Notable Quotes

“I am pleased that Theralase® has completed enrollment of 90 patients in its Phase II registrational clinical study for bladder cancer. This accomplishment allows the Company to complete this study in 2026 and prepare for Health Canada and FDA regulatory approval submissions.” – Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer

“Enrolling and treating 90 patients … represents a significant milestone… 2026 will be a pivotal year for the Company as we complete our bladder cancer study, embark on a combinational clinical study for bladder cancer and launch numerous Phase I/II adaptive clinical studies…” – Roger DuMoulin‑White, President & CEO