Theralase(R) Bladder Cancer Clinical Data to be Presented at the 2026 American Urological Association Annual Meeting

Executive Summary

• Theralase® Technologies’ interim Phase II data on light‑activated Ruvidar® (TLD‑1433) for BCG‑unresponsive non‑muscle invasive bladder cancer has been accepted for an interactive poster presentation at the 2026 American Urological Association Annual Meeting.
• Enrollment in Study II is complete; clinical data submission to Health Canada and the FDA will begin in Q3 2026, with regulatory approval anticipated in 2027.
• Interim results show encouraging efficacy: 2/3 patients achieved a complete response, 2/5 maintained that response ≥15 months, and 1/5 demonstrated a duration of response ≥3 years after a single treatment.

Key Details

• Presentation Acceptance: Abstract titled “Interim Analysis of Light‑Activated TLD‑1433 in a Phase II Clinical Study of BCG‑Unresponsive Non‑Muscle Invasive Bladder Cancer Carcinoma In‑Situ” approved for interactive poster at the AUA Annual Meeting (May 15‑18, 2026, Washington, DC).
• Study Design & Scope: International, multicenter Phase II “Study II” – 90 BCG‑unresponsive NMIBC CIS patients treated across 12 sites in Canada and the United States; interim data reported on 78 patients who have completed the study.
• Efficacy Highlights (Interim):
• Complete response observed in 2 of 3 evaluable patients.
• Sustained complete response ≥15 months in 2 of 5 evaluable patients.
• Duration of response ≥3 years in 1 of 5 evaluable patients after a single treatment.
• Safety: Interim data described as supporting a favorable safety profile (no specific adverse‑event numbers disclosed).
• Regulatory Timeline: Rolling submission of clinical data to Health Canada and the FDA slated for Q3 2026; pending regulatory approval expected in 2027, with commercial launch planned initially in Canada and the United States.
• Quotes:
• Dr. Wassim Kassouf (Principal Investigator): Emphasized meaningful safety and efficacy demonstrated in 78 patients, highlighting bladder‑preserving potential.
• Arkady Mandel, CSO: Highlighted high efficacy, significant duration of response, and favorable safety for BCG‑unresponsive NMIBC CIS patients.
• Roger DuMoulin‑White, CEO: Stressed the opportunity to showcase data internationally and outlined regulatory submission plans and commercial intent.

Notable Quotes

• “The interim clinical data of 78 patients… demonstrates meaningful safety and efficacy in the use of light‑activated Ruvidar®, as a treatment for BCG‑Unresponsive NMIBC CIS, thus helping patients to preserve their bladders and maintain their quality of life.” – Wassim Kassouf, MD, PhD
• “Light‑activated Ruvidar® has delivered a high efficacy, significant duration of response and favourable safety profile in BCG‑Unresponsive NMIBC CIS patients treated in Canada and the US.” – Arkady Mandel, MD, PhD, DSc
• “The acceptance of the Theralase® abstract… provides an opportunity for Theralase® to showcase the Study II clinical data to an international clinical audience… Pending successful regulatory approval… Theralase® plans to make this technology commercially available…” – Roger DuMoulin‑White, CEO